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We strive to achieve our vision and strategy through key objectives made possible with the proprietary technologies and services of the Align TM Digital Platform to establish:
−Removed: clear aligners as the principal solution for the treatment of malocclusions with the Invisalign System as the treatment solution of choice by orthodontists, GPs and patients globally, our iTero intraoral scanners as the preferred scanning technology for digital dental scans and our exocad CAD/CAM software as the dental restorative solution of choice for dental labs.
+Added: clear aligners as the principal solution for the treatment of malocclusions with the Invisalign System as the treatment solution of choice by orthodontists, GPs and patients
+Added: globally, our iTero intraoral scanners as the preferred scanning technology for digital dental scans and our exocad CAD/CAM software as the dental restorative solution of choice for dental labs.
Our corporate headquarters are located at 410 North Scottsdale Road, Suite 1300, Tempe, Arizona 85288.
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We also sell our products to dental laboratories who use our products to manufacture or customize their own products for licensed dentists.
−Removed: We furthermore market and sell doctor and consumer accessory products complementary to our doctor-prescribed principal products under the Invisalign® and other brands, including retainers, dental supplies, clear aligner cases (clamshells), ultrasonic and UV electronic cleaning devices, teeth whitening products and cleaning solutions (collectively, “Invisalign Accessory Products”).
+Added: We furthermore market and sell doctor and consumer accessory products complementary to our doctor-prescribed principal products under the Invisalign ® and other brand names, including retainers, dental supplies, clear aligner cases (clamshells), ultrasonic and UV electronic cleaning devices, teeth whitening products and cleaning solutions (collectively, “Invisalign Accessory Products”).
Depending on the product, our Invisalign Accessory Products are sold through a variety of channels, including online through large e-commerce websites, our doctor portal and in-store through large retailers and pharmacy stores.
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In order to provide Invisalign treatment to their patients, orthodontists and GPs must initially complete an Invisalign training course.
−Removed: Our iTero intraoral scanners are used by dental professionals, labs, and service providers for restorative and orthodontic digital procedures as well as Invisalign case submissions.
+Added: Our iTero intraoral scanners are used by dental professionals, labs, and service providers for restorative and orthodontic digital procedures, Invisalign case submissions, and comprehensive digital dentistry diagnosis, treatment planning and treatment monitoring.
Our exocad CAD/CAM software products provide restorative dentistry, implantology, guided surgery and smile design to dental labs and dental practices through fully integrated workflows, with the goal to provide cross-disciplinary dentistry in labs and at chairside.
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Align TM Digital Platform
−Removed: We strive to be at the forefront of innovation in digital orthodontics and dentistry, helping doctors transform their practices using digital tools and technology to deliver exceptional, modern treatment experiences and outcomes to patients worldwide.
−Removed: The Align TM Digital Platform is the foundation of our goal to revolutionize the practice of dentistry, delivering interconnected, interdisciplinary workflows and treatment solutions designed to improve all aspects of treatment, from initial consultations to final smiles with our doctor-centered treatment model.
−Removed: The Align TM Digital Platform is an end-to-end digital platform that combines software, systems and services to seamlessly integrate and connect those critical to successful treatment outcomes –
−Removed: doctors, labs, patients and consumers.
+Added: For nearly 30 years, Align has been transforming smiles and changing lives;
+Added: driving innovation in digital orthodontics and dentistry, helping doctors transform their practices using digital tools and technology to deliver exceptional, modern treatment
+Added: experiences and outcomes to over 22 million people worldwide.
+Added: The Align TM Digital Platform is the foundation of our goal to lead the digital revolution in orthodontics, restorative dentistry and comprehensive digital dentistry by delivering seamless workflows in dental practices, on mobile devices, and through remote monitoring, as well as diagnostic and treatment solutions designed to improve all aspects of assessment and treatment, from initial consultations to final smiles with our doctor-centered treatment model.
+Added: The Align TM Digital Platform is an end-to-end digital platform that combines software, systems and services designed to provide a seamless experience and end-to-end workflow that integrates and connects those critical to successful treatment outcomes – doctors, labs, patients and consumers.
At the center of the Align TM Digital Platform are Invisalign clear aligners, iTero intraoral scanners and exocad CAD/CAM software.
−Removed: The Align TM Digital Platform utilizes the Align TM Digital Workflow to enable an end-to-end digital treatment experience and generate interconnected workflows and treatment solutions, that includes the following key components:
+Added: The Align TM Digital Platform utilizes the Align TM Digital Workflow to enable an end-to-end digital treatment experience and generate interconnected workflows and treatment solutions.
+Added: The Align TM Digital Workflow includes dedicated tools and capabilities for each stage of the Invisalign treatment journey:
The initial stage of the platform drives consumer demand and connects potential patients to our websites and the websites of Invisalign providers.
−Removed: Some of the tools that support this stage are Invisalign.com, the Invisalign SmileView TM tool, My Invisalign app, Doctor Locator, Invisalign ® Practice App, and Invisalign ® Virtual Appointment.
+Added: Some of the tools that support this stage are Invisalign.com, Invisalign ® Doctor Locator, Invisalign SmileView TM tool, Invisalign ® Practice App, Invisalign ® Virtual Appointment and My Invisalign TM app.
During this stage, patient data is captured through intraoral scanning.
Doctors and their staffs use intraoral scanning tools designed to support diagnosis of a patient’s oral conditions and health and support doctors to develop appropriate treatment pathways.
−Removed: Visualization of their potential smiles helps patients understand the benefits of treatment and increase patient conversion.
−Removed: The tools that support this stage, include, iTero intraoral scanners and exocad CAD/CAM imaging systems, Invisalign ® Outcome Simulator Pro, Invisalign Photo Uploader, Invisalign SmileView TM tool, iTero Element TM 5D auto-upload feature, iTero TM Scan Report and iTero - exocad Connector TM .
+Added: Visualization of their potential smiles helps patients understand the benefits of treatment and increases patient conversion.
+Added: The tools that support this stage include iTero intraoral scanners and exocad CAD/CAM imaging systems, Invisalign ® Outcome Simulator Pro, iTero Element TM 5D auto-upload feature, iTero TM Near Infra-Red Imaging (NIRI) technology, iTero TM Scan Report, iTero TM TimeLapse Technology and iTero - exocad Connector TM .
Doctors can access and use tools that support diagnosis of a patient’s oral health and develop an appropriate treatment pathway.
The Align TM Digital Platform facilitates the doctor-patient conversation, through education regarding clinical needs and setting expectations.
−Removed: Some of the tools that support this stage include Align TM Oral Health Suite, iTero TM intraoral scanners, including those with NIRI technology (Near Infra-Red Imaging), iTero TM TimeLapse technology and iTero Occlusogram.
+Added: Some of the tools that support this stage include Align TM Oral Health Suite, Align X-ray Insights, iTero TM intraoral scanners, including those with NIRI technology, iTero TM TimeLapse technology and iTero TM Occlusogram.
Doctors digitally visualize and plan orthodontic and restorative treatments.
Orthodontists and GPs can use our products to design, build and share their vision for treatment planning and agree on a customized plan with their patients to reach the desired outcomes.
−Removed: Some of the tools that support this stage are ClinCheck ® Pro 6.0,ClinCheck ® Plan Editor, ClinCheck ® In-Face Visualization, ClinCheck ® Live Update, Invisalign ® Practice App, Invisalign ® Personalized Plan, CBCT Integration for ClinCheck ® software, Clincheck ® Smile Video, Invisalign Smile Architect TM , iTero TM Design Suite, exocad Dental CAD TM software and exocad Dental CAD™ 3.2 Elefsina software.
+Added: Some of the tools that support this stage are ClinCheck® Pro Software, 3D Controls in ClinCheck® Pro, ClinCheck® Plan Editor, Invisalign® Personalized Plan, CBCT integration for ClinCheck®, and Invisalign Smile Architect™.
During this stage, doctors treat their patients with our Invisalign ® clear aligners and may offer teeth whitening using the Invisalign TM Professional Whitening System.
−Removed: The Invisalign ® Palatal Expander System and the Invisalign ® System with mandibular advancement featuring enhanced precision wings are additional products that support patient treatment.
+Added: The Invisalign ® Palatal Expander System and the Invisalign ® System with mandibular advancement with occlusal blocks and enhanced precision wings, and SmartTrack™ material, SmartForce™ features and SmartStage™ technology are additional products that support patient treatment.
Doctors can remotely track their patients’ treatment between visits, and orthodontists and GPs can more easily track treatment progress and communicate issues, results and recommendations to their patients.
−Removed: Some of the tools that support this stage include Invisalign ® Virtual Care AI, My Invisalign TM app, Invisalign Doctor Site, Invisalign ® Practice App, Invisalign ® Progress Assessment and iTero TM scanners.
+Added: Some of the tools that support this stage include Invisalign ® Progress Assessment, Invisalign ® Virtual Care AI and My Invisalign TM app.
Following completion of their orthodontic treatment, patients can retain the final position of their teeth using Vivera TM retainers.
+Added: New Products/Feature Enhancement
As we further evolve the treatment planning experience for doctors through new technological research and development innovations, we expect to introduce new technologies, features and functionality that improve personalization of treatment planning, predictability, clinical preferences, and 2D/3D imaging, including digital tools for faster and more accurate final tooth positions.
−Removed: In 2024, we launched several new products and technologies that further enhance the Align TM Digital Platform, including the iTero Lumina TM intraoral scanner, iTero Multi-Direct Capture TM technology, Clincheck ® Smile Video, iTero TM Design Suite, Invisalign Smile Architect TM with treatment planning software with Multiple Treatment Plans, Invisalign ® Outcome Simulator with Multiple Treatment Simulation and Align TM Oral Health Suite with new comparison tools.
+Added: In 2025, we announced several new enhancements to the Align TM Digital Platform.
+Added: • In March 2025, we announced the addition of restorative capabilities to our iTero Lumina™ intraoral scanner (without iTero NIRI technology) and the new iTero Lumina™ Pro dental imaging system (with iTero NIRI technology).
+Added: • In March 2025, we also announced the launch in European Union countries and the United Kingdom of Align X-ray Insights, a new software-based (CADe*) computer aided detection solution that uses artificial intelligence (“AI”) to automatically analyze 2D radiographs.
+Added: • In October 2025, we announced a series of new innovations for iTero Digital Solutions, a comprehensive ecosystem that includes intraoral scanners and integrated software tools, including enhancements to the Align™ Oral Health Suite, Invisalign ® Outcome Simulator Pro with ClinCheck ® Smile Video, and the iTero™ Design Suite.
+Added: • In December 2025, we announced limited commercial availability of the Invisalign ® System with mandibular advancement featuring occlusal blocks (“MAOB”), the latest clinical innovation that expands Align’s Class II treatment portfolio by offering practitioners a comprehensive solution for treating growing patients with Class II malocclusions caused by mandibular retrusion.
Clear Aligner Segment
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We estimate that there are approximately 600 million people globally with malocclusion who could benefit from straightening their teeth.
−Removed: However, most people afflicted by malocclusion do not seek orthodontic treatment for various reasons, including negative perceptions of traditional metal wires and brackets, affordability of treatment, and accessibility to doctors.
+Added: However, most people afflicted by malocclusion do not seek orthodontic treatment for various reasons, including negative perceptions of traditional wires and brackets, affordability of treatment, and accessibility to doctors.
Annually, only approximately 22 million people globally elect treatment by orthodontists.
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Upon completion of a patient’s treatment, their dental professional may recommend the patient use a retainer appliance to preserve the benefits of their treatment.
−Removed: Of the 22 million cases started each year, we estimate that almost all can be treated using our Invisalign System, yet our share of the 22 million case starts through orthodontists is approximately 10% globally.
−Removed: Our business strategy remains focused on increasing our share of the existing market of orthodontic case starts compared to brackets and wires, especially among teens, and expand the market for digital orthodontics, especially among adults.
+Added: Of the 22 million cases started each year, we estimate that almost all can be treated using our Invisalign System, yet we estimate our share of the 22 million case starts through orthodontists is approximately 10% globally.
+Added: Our business strategy remains focused on increasing our share of the existing market of orthodontic case starts compared to wires and brackets, especially among teens, and expand the market for digital orthodontics, especially among adults.
By training more doctors, including GPs as well as orthodontists, increasing utilization of existing doctors using our products, educating more consumers about the benefits of straighter teeth using the Invisalign System and connecting consumers with an Invisalign-trained doctor of their choice, we are helping drive adoption of digital orthodontics and restorative dentistry globally.
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Diagnosis and transmission of treatment data .
−Removed: As part of the Align™ Digital Workflow, we have developed solutions to enable doctors to diagnosis and drive patient conversion from considering treatment to starting treatment – providing tools to support diagnosis of patients’ oral health and support to identify an appropriate treatment pathway, facilitating the doctor-patient conversation, education and clinical needs and expectations.
+Added: As part of the Align™ Digital Workflow, we have developed solutions to enable doctor diagnosis and drive patient adoption – providing tools to support diagnosis of a patient’s oral health and support to identify an appropriate treatment pathway, facilitating the doctor-patient conversation, education and clinical needs and expectations.
An Invisalign trained dental professional prepares an online prescription form on our Invisalign Doctor Site and securely submits the patient’s records, which include a digital intraoral scan or a polyvinyl-siloxane (“PVS”) impression of the relevant dental arches, photographs of the patient and, at the dental professional’s election, x-rays of the patient’s dentition.
Intraoral digital scans may be submitted through Align’s iTero scanner or certain third-party scanners capable of accurately interfacing with our systems and processes.
−Removed: Globally, approximately 94% of prescription orders for our Invisalign System are now submitted via digital scan, increasing the accuracy of treatment plans, reducing the time from when a doctor submits a prescription to the time a patient receives the clear aligners, and helping to decrease the carbon footprint resulting from elimination of the initial or upfront shipment of a patient’s PVS impressions to the doctors and shipping those PVS impressions back to us.
+Added: Globally, more than 95% of Invisalign System prescription orders are now submitted via digital scan, increasing the accuracy of treatment plans, reducing the time from when the doctor submits the prescription to the time the patient receives the clear aligners, and helping to decrease the carbon footprint resulting from elimination of the initial or upfront shipment of the patient’s PVS impressions to the doctors and shipping those PVS impressions back to us.
Computer-simulated treatment plan .
−Removed: Our ClinCheck ® Pro cloud-based treatment planning software is the cornerstone of the Align TM Digital Platform.
−Removed: ClinCheck Pro leverages proprietary algorithms based on the insights from data from over 19 million patients treated worldwide.
−Removed: Using the digital scans or PVS impressions, any specific doctor preferences and digital data provided, we generate a proposed custom, three-dimensional ClinCheck ® treatment plan using proprietary software developed through significant, ongoing research and development investments spanning over two decades.
+Added: Our ClinCheck ® treatment planning software is the cornerstone of the Align TM Digital Platform.
+Added: ClinCheck Pro treatment planning software uses proprietary algorithms based on the insights from data from our over 22 million patients treated worldwide.
+Added: Using the digital scans or PVS impressions, certain doctor preferences and digital data provided, we generate a proposed custom, three-dimensional treatment plan, called a ClinCheck ® treatment plan, using proprietary software developed through significant, ongoing research and development investments spanning more than two decades.
A patient’s ClinCheck treatment plan simulates desired tooth movement in stages and details the timing and placement of any features or attachments to be used during treatment.
−Removed: Attachments are tooth-colored shapes that can be affixed to a patient’s teeth to increase the biomechanical force on a specific tooth or teeth in order to affect the desired movement(s).
−Removed: Treatment plan review and approval by an Invisalign-trained doctor.
−Removed: The patient’s proposed ClinCheck treatment plan is then made available to the prescribing dental professional via our Invisalign Doctor Site, enabling the dental professional to evaluate projected tooth movement as it progresses from initial to final position and compare treatment plan options to best meet the dental professional’s treatment objectives.
−Removed: By reviewing, modifying as needed and approving an acceptable treatment plan, the dental professional retains control of the patient’s treatment.
+Added: Attachments are tooth-colored shapes that are sometimes used to increase the biomechanical force on a specific tooth or teeth in order to affect the desired movement(s).
+Added: Review and approval of the treatment plan by an Invisalign-trained doctor.
+Added: The patient’s ClinCheck treatment plan is then made available to the prescribing dental professional via our Invisalign Doctor Site, enabling the dental professional to evaluate projected tooth movement from initial to final position and compare, modify or choose from multiple treatment plan options to best meet the dental professional’s treatment objectives.
+Added: By reviewing, modifying as needed and approving the treatment plan, the dental professional retains control of the patient’s treatment.
Manufacture of custom clear aligners.
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From these molds, clear aligners are fabricated by pressure-forming polymeric sheets over each mold.
−Removed: Clear aligners are thin, clear polymer, removable dental appliances that are custom manufactured in a series designed to correspond to each stage of a patient’s ClinCheck treatment plan.
+Added: Clear aligners are thin, clear polymer, removable dental appliances that are custom manufactured in a series designed to correspond to each stage of the patient’s ClinCheck treatment plan.
Shipment to the dental professional and patient clear aligner wear.
−Removed: Once manufactured, each clear aligner for a patient’s doctor-approved treatment plan is typically shipped directly to the dental professional.
−Removed: The majority of doctors then distribute each clear aligner to their patients.
−Removed: Each set of clear aligners (one clear aligner for the lower and a second for the upper jaw) are generally worn for one week or for a short period of time corresponding to the stages of the patient’s approved ClinCheck treatment plan and their doctor’s discretion.
−Removed: The patient replaces their current set of clear aligners with the next pair in the series as and when prescribed, advancing tooth movement through each stage.
−Removed: At various points in each patient’s treatment, their doctor may place attachments or use other auxiliaries to achieve desired tooth movements, per their doctor’s original prescription and the approved ClinCheck treatment plan.
−Removed: Additionally, for patients treated using many of our Invisalign System products, doctors have the option to order additional clear aligners for doctor-approved treatment plan refinements.
+Added: Once manufactured, all the clear aligners for a patient’s doctor-approved treatment plan are typically shipped directly to the dental professional.
+Added: The majority of doctors then dispense all of the clear aligners to the patient.
+Added: Clear aligners are generally worn for one week or for a short period of time corresponding to the stages of the patient’s approved ClinCheck treatment plan and their doctor’s discretion.
+Added: The patient replaces their current set of clear aligners with the next set in the series when prescribed, advancing tooth movement through each stage.
+Added: At various points in each patient’s treatment, their doctor may place attachments or use other auxiliaries to achieve desired tooth movements, per the doctor’s original prescription and the approved ClinCheck treatment plan.
Clear Aligner Products
−Removed: We offer our Invisalign System in a variety of treatment packages designed to correspond with the case-by-case treatment needs of our doctors and their patients and also designed on nonclinical needs.
+Added: We offer our Invisalign System in a variety of treatment packages designed to correspond with the case-by-case treatment needs of our doctors and their patients and any nonclinical requirements.
The table below provides a general description of the categories of products in our Invisalign System offered in various regions as they typically correspond to the severity of malocclusion and length of anticipated treatment.
−Removed: Malocclusion Very Mild
−Removed: Product Invisalign® Express Package Invisalign® Lite Package Invisalign Go™ (GP)
−Removed: Invisalign® Moderate Packages (& Invisalign Go™ Plus) Invisalign® Comprehensive Packages
+Added: Malocclusion Very Mild to Mild
+Added: Mild to Moderate
+Added: Moderate to Severe
+Added: Product Invisalign ® Express Package
+Added: Invisalign ® Lite Package
+Added: Invisalign Go
+Added: Limited Movement
+Added: Invisalign ® Moderate Package
+Added: Invisalign ® Comprehensive Packages
Treatment Stages* 7 14 20 20-26 As many as required
−Removed: Clinical Scope Relapse and minor movement, anterior esthetic alignment Up to 2mm AP correction, crowding/spacing, lower incisor extraction, pre-restorative
−Removed: No AP correction, mild to moderate crowding, spacing, lower incisor extraction, pre-restorative tooth movement from 2nd premolar to 2nd premolar (5x5)
−Removed: Class I, mild AP correction, moderate crowding/spacing, mild anterior / posterior and vertical discrepancies, pre-restorative, (Go Plus tooth movement from 1st molar to 1st molar (6X6))
−Removed: Class I, II, III, moderate to severe crowding/spacing, anterior / posterior and vertical discrepancies, extractions, complex pre-restorative
+Added: Clinical Scope Relapse and minor movement, anterior esthetic alignment Class I, mild crowding/spacing, non-extraction, pre-restorative
+Added: Class I, no AP correction, mild to moderate crowding/spacing, non-extraction, pre-restorative.
+Added: Tooth movement from second pre-molar to second pre-molar (5x5)
+Added: Class I, mild Class II, mild to moderate crowding/spacing, mild AP and vertical discrepancies, pre-restorative
+Added: Class I, II, III, moderate to severe crowding/spacing, AP and vertical discrepancies, extractions, complex pre-restorative
* The number of stages can vary by product and region.
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The number and timing of additional clear aligner orders are subject to certain requirements noted in our terms and conditions.
+Added: In certain regions, we offer streamlined configurations with limited or no additional aligners, including the option to separately purchase additional aligners under applicable terms, and we anticipate offering these configurations in additional markets over time.
Comprehensive Products - Invisalign Treatment Options
Invisalign Comprehensive Packages .
−Removed: The Invisalign Comprehensive Package is used to treat adults and teens over a wide spectrum of mild to severe malocclusion and contains a broad variety of features to address the desired treatment goals.
−Removed: It also addresses the frequently complex orthodontic needs of teenage or younger patients with advanced features such as mandibular advancement, compliance indicators and compensation for tooth eruption.
+Added: Invisalign Comprehensive Packages are used to treat adults and teens over a wide spectrum of mild to severe malocclusion and contains a broad variety of features to achieve desired treatment goals.
+Added: They also address the frequently complex orthodontic needs of teenage or younger patients with advanced features such as mandibular advancement, compliance indicators and compensation for tooth eruption.
These packages include Invisalign Comprehensive, Invisalign First TM Phase 1 and Invisalign First TM Comprehensive Phase 2.
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After a patient completes Invisalign First Phase 1, doctors have the option to purchase a Comprehensive Phase 2 Package for that same patient.
−Removed: In the first quarter of 2023, we launched the Invisalign Comprehensive 3in3 product.
+Added: Invisalign Comprehensive 3in3 Package .
The 3in3 configuration offers doctors Invisalign Comprehensive treatment with a three-year treatment expiration date and three sets of additional clear aligners included prior to the treatment expiration date, rather than the five-year treatment expiration date with unlimited additional clear aligner sets prior to the treatment end date offered under the Invisalign Comprehensive Package.
+Added: Invisalign ® System With Mandibular Advancement Featuring Occlusal Blocks for Class II Skeletal and Dental Correction.
+Added: The Invisalign System with mandibular advancement featuring occlusal blocks expands our Class II treatment portfolio by offering practitioners a comprehensive solution for treating growing patients with late mixed or early permanent dentition (ages 10-16) with Class II malocclusions caused by mandibular retrusion.
+Added: Class II malocclusion is one of the most common orthodontic problems, characterized by a discrepancy in jaw alignment where the lower jaw (mandible) is positioned too far back relative to the upper jaw (maxilla) and represents approximately 30%-45% of malocclusions globally.
+Added: By leveraging the natural growth potential during pre-adolescence and adolescence, the Invisalign System with mandibular advancement featuring occlusal blocks facilitates effective correction of Class II malocclusions, helping to improve occlusal relationships, enhance facial aesthetics, and provides long-term functional benefits.
Non-Comprehensive Products - Invisalign Treatment Options
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Invisalign Go Packages.
−Removed: In various markets we also offer Invisalign Go TM , Invisalign Go TM Express and Invisalign Go Plus, which are streamlined non-comprehensive packages designed for GPs to more easily identify and treat patients with mild-to-moderate malocclusion cases, expand arch width, align anterior teeth prior to restorative treatment, and move teeth from second pre-molar to second pre-molar.
+Added: In various markets we also offer Invisalign Go TM , Invisalign Go TM Express and Invisalign Go TM Plus, which are streamlined non-comprehensive packages designed for GPs to more easily identify and treat patients with mild-to-moderate malocclusion cases, expand arch width, align anterior teeth prior to restorative treatment, and move teeth from second pre-molar to second pre-molar.
These packages include case assessment support, simplified ClinCheck treatment plans and a progress assessment feature for case monitoring.
+Added: Invisalign® Palatal Expander System.
+Added: In December 2023, we received 510(k) clearance in the United States for the Invisalign Palatal Expander System, a direct 3D printed orthodontic appliance design based on proprietary and patented technology.
+Added: Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and teeth, palate) with primary, mixed, or permanent dentition during orthodontic or orthopedic treatment in children or adolescents.
+Added: In adults, it is designed to be used in conjunction with surgery or other interventions when necessary.
+Added: The Invisalign Palatal Expander System consists of a series of removable devices staged in small increments of movement to expand a patient’s narrow maxilla to a position determined by their treating doctor.
+Added: Each direct 3D printed device is customized to the patient’s unique anatomy based on an iTero™ intraoral digital scan.
+Added: A palatal expansion treatment plan and device design are then developed using our proprietary orthodontic software.
+Added: The Invisalign Palatal Expander is our first direct 3D printed orthodontic device that provides doctors with a solution set to treat the most common skeletal and dental malocclusions in growing children.
+Added: Together with Invisalign First™ clear aligners, Invisalign Palatal Expanders can address early intervention treatment, such as Phase 1, an early interceptive orthodontic treatment for young patients.
+Added: The Invisalign Palatal Expander System is currently available in the United States, Canada, Australia, New Zealand, Hong Kong, Singapore, Vietnam, Japan, Thailand, India and certain countries in EMEA.
+Added: The Invisalign Palatal Expander System is expected to be commercially available in additional markets, pending regulatory approvals.
Non-Case Products
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Clear aligner non-case products include retention products, Invisalign training, adjusting tools used by dental professionals during the course of treatment, ancillary Invisalign Accessory Products and other oral health products available in certain e-commerce and retail channels in the United States.
−Removed: We offer up to four sets of custom clear aligners called Vivera retainers made with proprietary material strong enough to maintain tooth position and correct minor relapse, if necessary, as well as Invisalign retainers.
+Added: Vivera™ Retainers for Retention .
+Added: We offer up to four sets of Vivera retainers, which are custom clear aligners made with proprietary material strong enough to maintain tooth position and correct minor relapse, if necessary, as well as Invisalign retainers.
Retainers are generally available for doctors to offer to any of their patients, whether they use the Invisalign System or other products, including wires and brackets.
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Invisalign Professional Whitening System.
−Removed: Additionally, we offer a professional whitening system using Ultradent’s Opalescence PF whitening system with Invisalign ® clear aligners or Vivera retainers.
−Removed: New Products/Feature Enhancement
−Removed: Invisalign® Palatal Expander System.
−Removed: In December 2023, we received 510(k) clearance in the United States for the Invisalign Palatal Expanders.
−Removed: Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw) with primary, mixed, or permanent dentition.
−Removed: The Invisalign Palatal Expander System consists of a series of removable devices staged in small increments of movement to expand a patient’s narrow maxilla to a position determined by their treating doctor.
−Removed: Each direct 3D printed device is customized to the patient’s unique anatomy based on an iTero™ intraoral digital scan.
−Removed: A palatal expansion treatment plan and device design are then developed using our proprietary orthodontic software.
−Removed: The Invisalign Palatal Expander is our first direct 3D printed orthodontic device.
−Removed: Combined with Invisalign First™ Phase 1 clear aligners, Invisalign Palatal Expanders provide doctors with a full early intervention treatment solution such as Phase 1, an early interceptive orthodontic treatment for young patients.
−Removed: The Invisalign Palatal Expander System is currently available in the United States, Canada, Australia, New Zealand, Hong Kong, Singapore, Japan and certain countries in EMEA.
−Removed: The Invisalign Palatal Expander System is expected to be commercially available in additional markets, pending regulatory approvals.
−Removed: In January 2024, we completed the acquisition of Cubicure GmbH (“Cubicure”), a company that develops, produces and distributes innovative materials, equipment and processes for novel 3D printing solutions.
−Removed: We believe the acquisition of Cubicure will support our long-term growth strategy by enabling us to scale our 3D printing operations to eventually direct print millions of custom appliances per day.
−Removed: We expect the acquisition of Cubicure will ultimately extend and scale our printing, materials and manufacturing capabilities for our 3D printed products while concurrently materially reducing the amount of resin used in our manufacturing process.
+Added: The Invisalign™ Professional Whitening System, powered by Opalescence™, is the only professional teeth whitening system approved by Align for combined use with Invisalign® aligners and Vivera™ retainers.
+Added: Direct Fabrication
+Added: In January 2024, we completed the acquisition of Cubicure GmbH (“Cubicure”), a company that develops, produces and distributes proprietary direct 3D printing technologies that enable us to efficiently and sustainably manufacture our devices without the added step of first creating a mold.
+Added: We believe Cubicure provides direct fabrication capabilities that will support and scale our strategic innovation roadmap and strengthen the Align Digital Platform by enabling us to scale our 3D printing operations to eventually print millions of custom devices per day.
+Added: We expect this technology will ultimately extend and scale our printing, materials and manufacturing capabilities for our 3D printed product portfolio while concurrently materially reducing the amount of resin used in our manufacturing process.
Direct fabrication offers the transformative potential of design flexibility that goes beyond what the current thermoforming technology allows.
−Removed: This will potentially allow us to design unique appliances
−Removed: that may perform even better than our existing ones and address unmet market needs.
−Removed: We expect to pilot our first devices on this platform with 3D printed retainers in the first half of 2025.
+Added: This will potentially allow us to design unique appliances that may perform even better than existing appliances and address unmet market needs.
+Added: We have begun limited
+Added: manufacturing of certain appliances already, and expect to pilot additional devices, including retainers and certain pre-fab attachments, in limited releases in 2026.
Smart Technology:
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and Invisalign ® digital impression submission.
−Removed: iTero Scanner .
−Removed: The iTero Element™ portfolio of intraoral scanners includes the iTero Element™ 2, the iTero Element™ Flex, iTero Element™ 5D Imaging System, iTero Element™ Plus Series and the iTero Lumina™ intraoral scanner which are each available in select regions and countries.
+Added: iTero Element™ Scanner.
+Added: The iTero Element™ portfolio of intraoral scanners includes the iTero Element™ 2, the iTero Element™ Flex, iTero Element™ 5D imaging system, iTero Element™ Plus Series and the iTero Lumina™ which are each available in select regions and countries.
These products build on the existing high precision, full-color imaging and fast scan times of the iTero Element portfolio and are available with software options for orthodontic and restorative procedures.
The iTero scanner is interoperable with our Invisalign system such that a full arch or full mouth digital scan can be submitted as part of the Invisalign system prescription order submission process.
−Removed: Our iTero Element 5D Imaging System is the first integrated dental imaging system that simultaneously records 3D, intraoral color camera images, near infrared imaging (“NIRI”) technology and enables comparison over time using the iTero™ TimeLapse technology.
+Added: Our iTero Element 5D imaging system is the first integrated dental imaging system that simultaneously records 3D, intraoral color camera images, NIRI technology and enables comparison over time using the iTero™ TimeLapse technology.
NIRI technology, included in our iTero Element 5D and 5D Plus imaging systems, aids in detection and monitoring of interproximal caries above the gingiva in real time, without using harmful radiation.
−Removed: In October 2021, the findings of a clinical study we sponsored were published in the peer-reviewed Journal of Dentistry which demonstrated that the NIRI technology of the iTero Element 5D imaging system was 66% more sensitive than bitewing x-ray radiography for detection of interproximal lesions, without the use of harmful radiation.
−Removed: We received 510(k) clearance in the United States for the caries detection feature of the iTero Element 5D in 2020.
−Removed: The iTero Element Plus Series of intraoral scanners and imaging systems offers restorative and orthodontic digital workflows that include enhanced visualization for optimized patient
−Removed: experience, including a fully integrated 3D intraoral camera in certain models, seamless scanning with reduced processing time, artificial intelligence (“AI”)-based features, and, in certain models, NIRI technology.
+Added: The iTero Element 5D imaging system is available in the United States, Canada, China, and the majority of EMEA and select APAC and LATAM countries and is pending regulatory approval in others.
+Added: The findings of a clinical study we sponsored were published in the peer-reviewed Journal of Dentistry which demonstrated that the NIRI technology of the iTero Element 5D imaging system was 66% more sensitive than bitewing x-ray radiography for detection of interproximal lesions, without the use of harmful radiation.
+Added: We received 510(k) clearance in the United States for the caries detection feature of the iTero Element 5D imaging system in 2020.
+Added: The iTero Element Plus Series of intraoral scanners and imaging systems offers restorative and orthodontic digital workflows that include enhanced visualization for optimized patient experience, including a fully integrated 3D intraoral camera in certain
+Added: models, seamless scanning with reduced processing time, artificial intelligence (“AI”)-based features, and, in certain models, NIRI technology.
Our iTero Element scanners are offered in a number of software configurations such as Ortho Comprehensive, Restorative Comprehensive and Restorative Foundation.
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Our restorative software is designed for GPs, prosthodontists, periodontists and oral surgeons and includes restorative workflows providing the ability to send digital impressions to the lab of their choice and communicate seamlessly with external treatment planning, custom implant abutment, chairside milling and laboratory CAD/CAM systems such as through our iTero-exocad Connector TM .
−Removed: In January 2024, we launched the iTero Lumina intraoral scanner.
−Removed: The iTero Lumina intraoral scanner is designed with iTero Multi-Direct Capture TM technology that we believe quickly, easily and accurately captures more data while delivering exceptional scan quality and photorealistic images that remove the need for intraoral photos.
−Removed: iTero Multi-Direct Capture replaces the confocal imaging technology in earlier intraoral scanner models.
−Removed: It has a wider field of capture and multi-angled scanning that enables simultaneous capture from multiple angles.
−Removed: Additionally, the iTero Lumina scanner has a capture distance of up to 25mm, making it easier to scan complex oral regions such as narrow or deep palates, edentulous spaces, and partially erupted teeth with minimal maneuvering.
−Removed: It has a 50% smaller and 45% lighter wand (as compared to iTero Element™ 5D imaging system wand, excluding the wand cable), which is expected to be especially beneficial for kids and teen patients.
−Removed: The iTero Lumina scanner has photorealistic scans which enables high quality clinical decisions the same way intraoral photos do, and its advanced software enables scanning at two times the speed.
−Removed: We expect to launch the restorative software on the iTero Lumina intraoral scanner by the end of the first quarter of 2025.
−Removed: Invisalign® Outcome Simulator .
−Removed: The Invisalign Outcome Simulator is an exclusive chair-side and cloud-based application for the iTero scanner that allows doctors to help patients visualize how their teeth may look at the end of Invisalign treatment.
−Removed: This is achieved through a dual view layout that shows a prospective patient an image of their own current dentition next to a simulated final position after Invisalign treatment.
Invisalign® Progress Assessment Tool.
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This highlights areas of diagnostic interest to dental professionals and helps foster a proactive conversation with the patient regarding potential restorative or orthodontic solutions.
+Added: iTero Lumina™ Intraoral Scanner and iTero Lumina™ Pro Dental Imaging System
+Added: In January 2024, we launched the iTero Lumina intraoral scanner.
+Added: The iTero Lumina intraoral scanner is designed with iTero Multi-Direct Capture TM technology that captures more data quickly and accurately while delivering exceptional scan quality and photorealistic images that remove the need for intraoral photos.
+Added: iTero Multi-Direct Capture replaces the confocal imaging technology in earlier intraoral scanner models.
+Added: It has a wider field of capture and multi-angled scanning that enables simultaneous capture from multiple angles.
+Added: Additionally, the iTero Lumina scanner has a capture distance of up to 25mm, making it easier to scan complex oral regions such as narrow or deep palates, edentulous spaces, and partially erupted teeth with minimal maneuvering.
+Added: It has a 50% smaller and 45% lighter wand (as compared to iTero Element™ 5D imaging system wand, excluding the wand cable), which is expected to be especially beneficial for kids and teen patients.
+Added: The iTero Lumina scanner has photorealistic scans that are clinically comparable to intra-oral photography and its advanced software enables scanning at two times the speed.
+Added: In March 2025, we announced the addition of restorative capabilities to our next generation iTero Lumina™ intraoral scanner (without iTero NIRI technology) and the new iTero Lumina™ Pro dental imaging system (with NIRI technology) to enable efficient restorative and multidisciplinary ortho-restorative workflows and support diagnostic of interproximal caries above the gingiva, helping GPs reach new levels of practice efficiency and growth while delivering exceptional clinical outcomes.
+Added: Since October 2025, our portfolio of intraoral scanners have included a PC configuration (desktop and laptop) that extends the performance found in the cart and mobile configurations into a compact and adaptable format that integrates easily into existing practices.
+Added: The enhanced capabilities of the iTero Lumina solutions provide an improved scanning experience and performance, optimal for the simplest to the most challenging restorative cases.
+Added: These capabilities are complemented by simplified restorative workflows that include the capture of single unit dental crowns to full dental arch with multiple preparations in a single pass, with a wave of an iTero Lumina wand.
+Added: iTero™ Digital Solutions
+Added: In October 2025, we announced a series of new product innovations for iTero™ Digital Solutions, a comprehensive ecosystem that includes intraoral scanners and integrated software tools designed to transform dental consultations into a modern, multi-modal oral health assessment that helps doctors and their teams deliver exceptional chairside experiences.
+Added: These new capabilities span across key practice workflows that underline the Align™ Digital Workflow including Diagnose, Plan, Treat, and Monitor steps.
+Added: From dynamic and personalized visualization and patient engagement tools at chairside, to expanded compatibility with 3D printers and milling machines, these new innovations are designed to simplify workflows, increase patient acceptance, and drive practice growth.
Align TM Oral Health Suite .
−Removed: The Align™ Oral Health Suite is a digital interface designed to enhance dental consultations and drive patient acceptance of dental treatment.
−Removed: It offers a modern approach to dental examinations, featuring an innovative clinical framework designed to empower doctors and their clinic staff to conduct comprehensive oral health assessments via a single scan using patient-friendly terminology, and providing a highly engaging patient-centric experience.
−Removed: It integrates iTero diagnostic aid and visualization tools, such as iTero NIRI, iTero Occlusogram, iTero TimeLapse and Invisalign Outcome Simulator Pro into a single interface chairside on the iTero scanner.
+Added: The Align™ Oral Health Suite is designed to be an intuitive and visually engaging digital interface intended to enhance patient-driven interest and engagement with iTero Element™ Plus and iTero Lumina™ scan images to help drive doctor-patient conversations about treatment options earlier in the patient journey.
+Added: The all-in-one chairside consultation can help patients see their oral health conditions, discuss potential root causes with their doctors and evaluate treatment options.
+Added: Invisalign® Outcome Simulator Pro .
+Added: Invisalign Outcome Simulator Pro is a patient communication tool on iTero Element™ Plus Series and iTero Lumina™ imaging systems, that generates highly realistic, simulated in-face visualizations of a patient’s potential future smile after an orthodontic or ortho-restorative treatment.
+Added: Invisalign Outcome Simulation Pro with multi treatment simulations offers two types of simulations chairside:
+Added: Invisalign for ortho-only, and Invisalign Smile Architect™ for ortho-restorative.
+Added: The new Invisalign ® Outcome Simulator Pro with Smile Video offers dynamic in-face visualization at chairside designed to improve patient conversion.
+Added: iTero™ Design Suite .
+Added: iTero™ Design Suite offers doctors and dental staff a simple and intuitive digital chairside design workflow for 3D printing and milling of models, bite splints, mock-ups, and restorations to enable single-visit dentistry and better patient experiences.
+Added: It includes comprehensive printing and milling compatibility, a new mock-up workflow that drives patient engagement and treatment acceptance, and the integration of iTero NIRI and HD intraoral images into the Suite to help trace the margin line and support detailed restoration design.
CAD/CAM Service s.
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Over the past 28 years, Align has helped doctors treat over 22 million patients with the Invisalign System and is driving the evolution in digital dentistry through the Align TM Digital Platform.
−Removed: Our technology and innovations are designed to meet the demands of today’s patients with convenient, comfortable and affordable treatment options, while improving overall oral health.
+Added: Our technology and innovations are designed to meet the demands of today’s patients with advanced technologies improving doctors’ diagnostic capabilities along with treatment options that are effective, convenient, comfortable and affordable to improve overall oral health.
We strive to help doctors and lab technicians move their businesses forward by connecting them with new patients, providing digital solutions that increase operational speed and efficiency and provide solutions that allow them to deliver exceptional treatment outcomes and experiences to millions of people around the world.
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• International Expansion.
−Removed: We continue increasing our presence globally by increasing awareness of our products and by making them available in more countries to more customers and consumers.
−Removed: We continue expansion of our sales and marketing by reaching into new countries and regions, including new areas in Africa and Latin America.
+Added: We continue growing our global presence by increasing awareness of our products and making them available in more countries to more customers and consumers.
+Added: We continue expansion of our sales and marketing by reaching into new countries and regions, including new areas in Africa, Asia and Latin America.
As of the end of 2025, we are selling directly or through authorized distributors in more than 100 countries.
−Removed: As our business continues to grow in both number of new Invisalign-trained doctors and customer utilization, we support that growth through targeted investments such as clinical support, product improvements, technological innovations, clinical education and advertising.
+Added: We support our growth through targeted investments in clinical support, product improvements, technological innovations, clinical education and advertising.
In addition, we are scaling and expanding our operations and facilities to better support the growing numbers of global customers.
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Americas (Mexico), APAC (China), and EMEA (Poland).
−Removed: Each of these three facilities form the foundation of our manufacturing strategy, which continues to evolve to increase flexibility and optimize our capacity and cost structure.
+Added: Each of these facilities form the foundation of our manufacturing strategy, which continues to evolve to increase flexibility and optimize our capacity and cost structure.
We also perform digital treatment planning and interpretation for restorative cases worldwide, including in Costa Rica, China, Germany, Spain, Poland, and Japan, among others.
By establishing and expanding our key operational activities in locations closer to our customers, we are creating an infrastructure that allows us to be responsive to local and regional needs, while providing global operational flexibility and scale needed for variations in global and regional demand.
−Removed: We expect to continue expanding our business in 2025 by investing in resources, infrastructure and initiatives that help drive Invisalign treatment growth, position our iTero intraoral scanners as the preferred scanning technology for digital dental scans, and establish our exocad CAD/CAM software as the solution of choice for dental labs in existing and new international markets.
+Added: We expect to continue expanding our business by investing in resources, infrastructure and initiatives that help drive Invisalign treatment growth, position our iTero intraoral scanners as the preferred scanning technology for digital dental scans, and establish our exocad CAD/CAM software as the solution of choice for dental labs in existing and new markets.
• GP Dentist Treatment .
−Removed: We strive to enable GPs, who have the potential to treat the general patient population, to more easily identify potential cases they can treat with the Invisalign System, monitor patient progress or, if needed, help refer cases to an orthodontist while providing high-quality restorative, orthodontic and dental hygiene care.
+Added: We strive to enable GPs, who treat the general patient population, to more easily identify potential cases they can treat with the Invisalign System, monitor patient progress or, if needed, help refer cases to orthodontists while providing high-quality restorative, orthodontic and dental hygiene care.
We believe success with GPs can be achieved through doctor training and clinical education, by offering digital tools such as the iTero intraoral scanner and products like Invisalign Go™ treatment that address the distinctive needs of GP patients, all delivered by sales and marketing personnel specifically focused on the unique needs of this customer category.
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We have well established relationships with many DSOs globally that recognize the benefits of digital workflows enabled by our portfolio of products and services that make up the Align TM Digital Platform, including increased practice efficiency and profitability, as well as delivering a better patient experience from shorter cycle times and customer proximity.
−Removed: We have and may continue to financially invest in or explore collaborations with key ecosystem partners, including DSOs, whose missions and visions align with our own vision, strategy, business model and goals.
+Added: We have and may continue to financially invest in or explore collaborations with key ecosystem partners, including DSOs, whose missions and visions align with our vision, strategy, business model and goals.
• Patient Demand.
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The initial stage of the Align TM Digital Platform drives consumer demand and connects potential patients to our websites and the websites of Invisalign providers.
−Removed: Some of the tools that support this stage are Invisalign.com, the Invisalign SmileViewTM tool, My Invisalign app, Doctor Locator, Invisalign® Practice App, and Invisalign® Virtual Appointment.
+Added: Some of the tools that support this stage are Invisalign.com, Doctor Locator, Invisalign SmileView TM tool, Invisalign ® Practice App, Invisalign ® Virtual Appointment and My Invisalign TM app.
The Align TM Digital Platform also facilitates the doctor-patient conversation, through education regarding clinical needs and setting expectations.
−Removed: Some of the tools that support this stage include
−Removed: Align™ Oral Health Suite, that integrates iTero diagnostic aid and visualization tools, such as iTero NIRI, iTero Occlusogram, iTero TimeLapse and Invisalign Outcome Simulator Pro with multiple treatment plans.
−Removed: • Orthodontist Utilization.
+Added: Further to our commitment to diagnostic innovation and our ongoing efforts to expand our digital platform, we launched the Align™ Oral Health Suite in 2025, which integrates iTero diagnostic aid and visualization tools, and broadens the holistic approach we offer to GP dentists and orthodontists to support earlier patient interaction for diverse treatment options in oral health, restorative and aesthetic dentistry.
+Added: • Orthodontic Utilization.
We continue to innovate and increase product applicability and predictability to address a wide range of cases, from simple to complex, thereby enabling doctors to confidently diagnose and treat children and adults with the Invisalign System.
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and Wroclaw, Poland.
−Removed: We believe this allows us to better serve our global customer base by being closer to our doctor customers and driving efficiencies in the business.
+Added: We believe this allows us to better serve our global customer base by being closer to our customers and driving efficiencies in the business.
We produce our handheld intraoral scanner wand, perform final scanner assembly and repair our scanners at our facilities in Ziyang, China and Petah Tikva, Israel and also perform final scanner assembly in Blonie, Poland and Juarez, Mexico;
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Systems, processes and procedures are implemented to ensure high levels of product and service quality.
−Removed: We monitor the effectiveness of the quality system based on internal data and direct customer feedback and strive to continually improve our systems and processes, taking corrective action, as needed.
−Removed: Since the mass-customized treatment planning and manufacturing processes of our products requires substantial and varied technical expertise, we believe our manufacturing capacity and capabilities are important to our success.
+Added: We monitor the effectiveness of the quality system based on internal data
+Added: and direct customer feedback and strive to continually improve our systems and processes, taking corrective action, as needed.
+Added: Since the mass-customized treatment planning and manufacturing processes of our products require substantial and varied technical expertise, we believe our manufacturing capacity and capabilities are important to our success.
In order to produce our highly-customized, highly-precise, medical quality products in volume, we have developed a number of proprietary processes and technologies.
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To increase the efficiency and yield of our manufacturing processes, we continue to focus our efforts on software development, equipment development and the improvement of rate-limiting processes or bottlenecks.
−Removed: In addition, we have invested in developing technologies that will allow us to directly print the devices that may help us improve and streamline the processes as well as the performance of devices.
−Removed: We continuously upgrade our proprietary, three-dimensional treatment planning software to enhance computer analysis of treatment data and to reduce time spent on manual and judgmental tasks for each case, thereby increasing the efficiency of our technicians.
+Added: In addition, we have invested in developing technologies that allow us to directly print the devices to improve and streamline the processes as well as the performance of devices.
+Added: We continuously upgrade our proprietary, three-dimensional treatment planning software to enhance computer analysis of treatment data and reduce time spent on manual and judgmental tasks for each case, thereby increasing the efficiency of our technicians.
Moreover, to improve efficiency and increase the scale of our operations, we continue to invest in the development of automated systems for the fabrication and packaging of clear aligners.
−Removed: In addition, predictable and consistent production is essential to our commitment to timely deliver products to our customers efficiently and profitably.
+Added: In addition, predictable and consistent production is essential to timely deliver products to our customers efficiently and profitably.
Our production can be disrupted by such things as supply chain and shipping issues, production manufacturing software system issues, quality and safety issues, and production equipment downtime.
−Removed: Accordingly, as we have grown our operations, we have included flexibility and resiliency in our overall manufacturing design to mitigate the risks of production downtime.
+Added: Accordingly, as we have grown our operations, we have included flexibility and resiliency in our overall manufacturing design to mitigate against risks of production downtime.
Our manufacturing facilities include backup generators and systems and each facility has an emergency response plan that is part of ongoing employee training and testing through recurring cross functional scenario-based simulation exercises.
−Removed: Likewise, having manufacturing facilities in key regions provides us with greater flexibility and capacity to adjust and redirect production to one or more of our production facilities as needed.
−Removed: As part of our manufacturing resiliency design efforts, we have also considered climate change and climate-related risks such as higher average global temperatures, rising sea levels and more frequent and severe wildfires, hurricanes, floods, winter storms, heat waves and other events and natural disasters (collectively, “climate-related risks”).
+Added: Likewise, having manufacturing facilities in key regions provides greater flexibility and capacity to adjust and redirect production as needed.
+Added: As part of our manufacturing resiliency design efforts, we have also considered climate change related risks such as higher average global temperatures, rising sea levels and more frequent and severe wildfires, hurricanes, floods, storms, heat waves and other events and natural disasters (collectively, “climate-related risks”).
We view climate-related risks to be one of many operational challenges we face and factor them into our business continuity planning and strategic risk mitigation efforts.
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Our California, Costa Rica, Mexico and North Carolina operations are located in areas that have historically been impacted by extreme weather events such as hurricanes, tornados, wildfires or flooding.
−Removed: In part to help mitigate risks to our manufacturing operations, we have strategically located our clear aligner production facilities in three facilities on different continents.
+Added: In part to help mitigate risks to our manufacturing operations, we have strategically located our clear aligner production facilities on three different continents.
This allows us to both respond more quickly to customer demand while also offering redundancy in the event natural disasters or climate-related events affect operations at one or more facilities.
−Removed: Moreover, each of our three key clear aligner manufacturing facilities are located at elevations less likely to be impacted by rising sea levels and at least two hundred miles inland.
+Added: Moreover, each of our key clear aligner manufacturing facilities are located at elevations less likely to be impacted by rising sea levels and at least two hundred miles inland.
Moreover, we are highly dependent on manufacturers of specialized scanning equipment, rapid prototyping machines, resin and other advanced materials for our clear aligners, as well as the optics, electronic and other mechanical components of our intraoral scanners.
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Sales and Marketing
−Removed: Our sales and marketing efforts are focused on increasing adoption and utilization of the Invisalign System and Vivera retainers by orthodontists and GPs worldwide and integrating the iTero scanner and services and exocad CAD/CAM products into dental labs and practices.
+Added: Our sales and marketing efforts are focused on increasing adoption and utilization of the Invisalign System and Vivera retainers by orthodontists and GPs and integrating the iTero scanner and services and exocad CAD/CAM products into dental labs and practices.
The iTero scanner is an important component to the customer experience and is central to a digital approach as well as overall customer utilization of Invisalign clear aligners.
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We also have distribution partners in certain markets.
−Removed: Our sales and marketing personnel are organized primarily to support orthodontists and GPs separately, allowing highly trained and specialized personnel to serve each customer channel, thereby increasing our focus and effectiveness on both.
+Added: Our sales and marketing personnel are organized primarily to support orthodontists and GPs, allowing highly trained and specialized personnel to serve each customer channel, thereby increasing our focus and
+Added: effectiveness on both.
We continue to expand in existing markets through targeted investments in sales resources, professional marketing and education programs.
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We define doctors as active if they have submitted at least one Invisalign case in the prior 12-month period.
+Added: To drive further adoption by additional doctors and increase utilization by existing doctors, we are, among other things, continuing to move key operations closer to our customers, simplifying our Advantage rebate program, launching new offerings, expanding our zero AA configuration, aligning our sales teams to market demographics, and deepening our commitment to consumer marketing.
Research and Development
−Removed: We are committed to investing in world-class digital technology development, which we believe is critical to achieving our goal of establishing the Invisalign System as the standard method for treating malocclusion, our iTero intraoral scanners as the preferred scanning technology for digital dental scans, and our exocad CAD/CAM software as the solution of choice for dental labs.
−Removed: Our research and development activities are directed toward developing digital technology innovations that we believe will deliver our next generation of products and solutions as part of the Align TM Digital Platform.
−Removed: These activities range from accelerating product and clinical innovation, to developing manufacturing process improvements, to researching future technologies, products and software.
−Removed: In an effort to demonstrate the broad treatment capabilities of the Invisalign System, more than 200 peer-reviewed publications and various clinical case studies and articles have been published that highlight the clinical applicability of Invisalign treatment to malocclusion cases, including addressing malocclusions of severe complexity.
−Removed: Similarly, various studies have also been published demonstrating the capabilities of our scanners, including advanced features such as our NIRI technology.
+Added: We are committed to investing in world-class digital and clinical technology development, which we believe is critical to achieving our goal of establishing the Invisalign System as the standard method for treating malocclusion, our iTero intraoral scanners as the preferred scanning technology for digital dental scans, and our exocad CAD/CAM software as the solution of choice for dental labs.
+Added: Our research and development activities are directed toward developing digital technology innovations we believe will deliver our next generation of products and solutions as part of the Align TM Digital Platform.
+Added: These activities range from accelerating product and clinical innovation, to developing treatment planning and manufacturing process improvements, to researching future technologies, products and software.
+Added: The treatment capabilities of the Invisalign System have been demonstrated by more than 800 peer-reviewed publications and various clinical case studies and articles have been published that highlight the clinical applicability of Invisalign treatment as a means to effectively treat a broad spectrum of malocclusions across permanent and mixed dentitions, including addressing malocclusions of severe complexity.
+Added: Similarly, various studies have been published demonstrating the capabilities of our iTero Lumina solutions, including advanced features such as our NIRI technology, and we have conducted internal clinical validation research supporting the conclusion that iTero Lumina photorealistic scans are clinically comparable to intra-oral photography.
We undertake pre-commercialization trials and testing of our technological improvements to our products and manufacturing process.
−Removed: We furthermore fund research in the field of orthodontics and dentistry through initiatives such as our
−Removed: Annual Research Award Program, which was in its 15th year in 2024 and donations to the American Association of Orthodontists Foundation.
+Added: In September 2025, we launched an enhanced clinical evidence webpage containing an expansive library of peer-reviewed clinical research publications and the Align Global Gallery™, a searchable database of more than 1,500 real-world Invisalign treatment cases by doctors from around the world.
+Added: We furthermore fund research in the field of orthodontics and dentistry through initiatives such as our Annual Research Award Program, which was in its 16th year in 2025 and donations to the American Association of Orthodontists Foundation.
Intellectual Property
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We also seek to protect our software, documentation and other written materials under trade secret and copyright laws.
−Removed: We furthermore have a broad and diverse trademark portfolio that we use to highlight and protect our universally recognized brands.
+Added: We furthermore have a broad and diverse trademark portfolio that we use to highlight and protect universally recognized brands.
Information regarding risks associated with our proprietary technology and our intellectual property rights may be found in Part I, Item 1A of this Annual Report on Form 10-K under the heading “Risk Factors.”
Seasonal Fluctuations
−Removed: General economic conditions impact our business and financial results, and we have historically experienced seasonal trends within our two operating segments, customer channels and the geographic locations that we serve.
+Added: General economic conditions impact our business and financial results, and we have historically experienced seasonal trends within our two operating segments, customer channels and geographic locations we serve.
Sales of the Invisalign System are often weaker in Europe, especially southern European countries during the summer months and seasonally higher in China during the third quarter.
Similarly, other international holidays like Lunar New Year can impact our sales in APAC in the first quarter.
−Removed: In North America, summer is typically the busiest season for orthodontists with practices that have a high percentage of adolescent and teenage patients as many parents start their children in treatment before the school year begins.
+Added: In North America, summer is typically the busiest season for orthodontists that have a high percentage of adolescent and teenage patients as many parents start their children in treatment before the school year begins.
Conversely, many GPs are on vacation during this time and therefore tend to start fewer cases.
For our Systems and Services segment, capital equipment sales are often stronger in the fourth calendar quarter.
−Removed: However, many of these typical seasonal patterns have been impacted by changes in foreign exchange rates, military conflicts, inflation and other macroeconomic challenges.
−Removed: It remains unclear when or if these seasonal fluctuations will return to historical norms.
+Added: However, many of these typical seasonal patterns have been impacted by changes in foreign exchange rates, military conflicts, inflation, trade policies and other macroeconomic challenges.
+Added: unclear when or the extent to which these seasonal fluctuations will return to historical norms.
Consequently, seasonal trends have and may continue to cause fluctuations in our quarterly results, including fluctuations in sequential revenue growth rates.
−Removed: Competition in the clear aligner market continues to increase.
−Removed: Our clear aligner products compete directly against traditional orthodontic treatments that use metal brackets and wires and increasingly against clear aligner products manufactured and distributed by various companies, both within and outside the United States.
−Removed: Although the number of competitors varies by segment, product, geography and customer, they include new and well-established regional competitors in certain foreign markets, as well as larger companies, divisions of larger companies or well-capitalized new entrants with substantial sales, marketing, research and financial capabilities.
−Removed: We also compete with direct-to-consumer (“DTC”) companies that provide clear aligners directly to the consumer requiring little or no in-office care from doctors and also from doctors themselves who can manufacture retainers and custom clear aligners using 3D printing technology.
−Removed: In addition, corresponding foreign patents began expiring in 2018 which has increased competition outside the United States.
+Added: Our clear aligner products compete directly against traditional orthodontic treatments that use wires and brackets and increasingly against clear aligner products manufactured and distributed by various companies, both within and outside the United States.
+Added: Although the number of competitors varies by segment, product, geography and customer, they include new and well-established regional competitors in certain foreign markets, as well as larger companies, divisions of larger companies or well-capitalized new entrants with substantial sales, marketing, research and financial capabilities at cost-effective rates.
+Added: We also compete with direct-to-consumer (“DTC”) companies that provide clear aligners directly to consumers requiring little or no in-office care from doctors and also from doctors who manufacture retainers and custom clear aligners using 3D printing technology.
Additionally, we face competition in the rapidly evolving markets for intraoral scanners and software solutions, including CAD/CAM.
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We believe we are well positioned to compete in the markets we target.
−Removed: We have thousands of dedicated, highly skilled sales force employees who are focused on key demographics in our target markets that allow us to uniquely address customer needs and thereby enhance the customer experience.
+Added: We have thousands of dedicated, highly skilled sales force employees who are focused on key portions of our target markets that allow us to uniquely address customer needs and thereby enhance the customer experience.
Our significant historical and ongoing investments in research and development and design around the movement of teeth, SmartTrack aligner materials and design, intraoral scanning, 3D manufacturing, global scale of manufacturing and treatment planning, strong brand name recognition, strong workforce, diversified and knowledgeable customer base, geographic expansion, reliable financial results, leading digital platform, technology and IP, next wave of innovation with direct 3D printing and innovations powered by AI enabling more personalized care, and regulatory clearance of our products are among a few of our key competitive factors that compare favorably with our competitors’ products and services.
Government Regulations
−Removed: Many countries throughout the world have established regulatory frameworks for commercialization of medical devices.
+Added: Many countries have established regulatory frameworks for commercialization of medical devices.
As a designer, manufacturer, and marketer of medical devices, we are obligated to comply with the respective frameworks of these countries to obtain and maintain access to these global markets.
The frameworks often define requirements for marketing authorizations which vary by country.
−Removed: Failure to obtain appropriate marketing authorization and to meet all local requirements, including specific quality and safety standards and new software and AI standards in any country in which we currently market our products, could cause commercial disruption and/or subject us to sanctions and fines.
+Added: Failure to obtain appropriate marketing authorization and meet all local requirements, including specific quality and safety standards and new software and AI standards in any country in which we market our products, could cause commercial disruption and/or subject us to sanctions and fines.
Delays in receipt of, or a failure to receive, such marketing authorizations, or the loss of any previously received authorizations, could have a material adverse effect on our business, financial condition and results of operations.
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and disclosure of payments to healthcare professionals and institutions.
−Removed: As we expand our operations footprint, countries to which we sell and invest in new business models, compliance with applicable laws becomes more complex and the general trend is toward increasingly stringent oversight and enforcement.
+Added: As we expand our operations, compliance with applicable laws in countries in which we sell and invest in new business models becomes more complex and the general trend is toward increasingly stringent oversight and enforcement.
Initiatives sponsored by government agencies, legislative bodies, and the private sector to limit the growth of healthcare expenses generally are ongoing in markets where we do business.
−Removed: It is not possible to predict at this time whether these trends will impact our business or the potential cost containment measures on our future business.
−Removed: Our customers are healthcare providers that may be reimbursed by state or federal funded programs such as Medicaid, a foreign national healthcare program, or private pay insurance, each of which may offer some degree of oversight.
+Added: It is not possible to predict whether these trends will impact our business or the potential cost containment measures on our future business.
+Added: Our customers are healthcare providers who may be reimbursed by state or federal funded programs such as Medicaid, a foreign national healthcare program, or private pay insurance, each of which may offer some degree of oversight.
As a medical device manufacturer and seller, we are subject to transparency reporting laws (also known as sunshine laws) that in certain countries and U.S.
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Enforcement actions and associated efforts to respond or defend against enforcement actions can be expensive, and any resulting findings carry the risk of significant civil and criminal penalties.
−Removed: In addition, we must comply with numerous laws and regulations addressing privacy, data protection, data governance and cyber security.
+Added: In addition, we must comply with numerous laws and regulations addressing privacy, data protection, artificial intelligence, data governance and cybersecurity.
+Added: We are subject to the European Union General Data Protection Regulation 2016/679 and any applicable national implementing laws (together, the “EU GDPR”), as well as the United Kingdom General Data Protection Regulation and the Data Protection Act 2018 (together, the “UK GDPR”).
+Added: Collectively, these are referred to as the “GDPR.” The GDPR establishes broad data privacy requirements regarding our collection, processing, sharing, disclosure, transfer, and other uses of information relating to identifiable living individuals.
+Added: These requirements include principles of accountability and the obligation to demonstrate compliance through the implementation of appropriate policies, procedures, training, and audits.
Many of these laws and regulations do or will soon regulate or restrict cross-border data transfers, such as in the United States, the EU, Switzerland, Brazil, China, Vietnam, Japan, Korea, Australia, New Zealand, the Kingdom of Saudi Arabia, Hong Kong and other countries.
Further, in the United States, we may be required to comply with laws and regulations addressing the collection, use, security and processing of protected health information and other information relating to individuals, including the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and its implementing rules.
−Removed: The HIPAA Standards for Privacy of Individually Identifiable Health Information (“Privacy Standards”) and the Security Standards for the Protection of Electronic Protected Health Information under HIPAA and the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”) (the “Security Standards”) are the subjects of final and proposed rule amendments, respectively, reflecting the rapidly evolving nature of these laws and regulations.
Additionally, many U.S.
states maintain laws and regulations addressing privacy, data protection, data governance and cybersecurity.
−Removed: Like many other companies, we must work to ensure our global privacy program framework incorporates applicable requirements of new and modified laws and regulations in relevant jurisdictions to support our efforts to ensure that our product innovations and our associated practices comply with these increasingly complex laws and regulations.
−Removed: Legislatures and regulators globally are proposing, and in certain cases have enacted, new laws or regulations regarding privacy, data protection, data governance and cybersecurity that could require us to modify our policies and practices in order to comply with new and evolving obligations relating to these matters.
+Added: Like many other companies, we must work to ensure our global privacy program framework incorporates applicable requirements of new and modified laws and regulations in relevant jurisdictions to support our efforts to ensure our product innovations and associated practices comply with these increasingly complex laws and regulations.
+Added: Legislatures and regulators globally are proposing, and in certain cases have enacted, new laws or regulations regarding privacy, data protection, artificial intelligence, data governance and cybersecurity that could require us to modify our policies and practices in order to comply with new and evolving obligations relating to these matters.
Information regarding risks associated with data security and privacy may be found in Part I, Item 1A of this Annual Report on Form 10-K under the heading “ Risk Factors .”
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Align is committed to building a global workforce with varied cultural backgrounds and life experiences.
−Removed: Fostering a culture of dignity, integrity, open dialogue, open-mindedness, compassion, fairness, recognition, and shared goals allows us to attract and retain the best talent, and provide a safe and supportive environment that allows our employees to excel.
+Added: Fostering a culture of dignity, integrity, open dialogue, open-mindedness, compassion,
+Added: fairness, recognition, and shared goals allows us to attract and retain the best talent, and provide a safe and supportive environment that allows our employees to excel.
As of December 31, 2025, we had approximately 20,290 employees, a decrease of approximately 3.1% and 6.1% over December 31, 2024, and December 31, 2023, respectively.
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We seek to create an environment that values the health, safety and well-being of our teams, and we work to equip them with the knowledge and skills to serve our business and develop their careers.
−Removed: We believe that by effectively managing our business with these values as the foundation, we will drive long-term value for our stockholders and all stakeholders.
−Removed: As part of our Board’s commitment to our employees and communities, our Board has delegated oversight responsibility of our policies and practices that foster Align’s sustainability and cultural initiatives, policies, practices, and programs to our
−Removed: Nominating and Governance Committee.
+Added: We believe that by effectively managing our business founded on these values, we are driving long-term value for our stockholders and all stakeholders.
+Added: As part of our commitment to our employees and communities, our Board has delegated oversight responsibility of our policies and practices that foster Align’s sustainability and cultural initiatives, policies, practices, and programs to our Nominating and Governance Committee.
Additionally, our Compensation and Human Capital Committee has oversight responsibilities of all human capital management strategies, programs and policies.
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Our work culture is designed to create financial, health, career and personal benefits for our employees and organization.
−Removed: We sponsor cultural recognition events to increase awareness of inclusion and belonging, including its importance in creating an environment where every employee is safe, supported and can thrive.
−Removed: Our employees have also established and manage employee groups including employee resource groups which are based on shared characteristics or life experiences.
+Added: We sponsor cultural recognition events to increase awareness of inclusion and belonging, including its importance in creating an environment where every employee feels safe, supported and can thrive.
+Added: Our employees have also established and manage employee groups including employee resource groups based on shared characteristics or life experiences.
These are open to all employees, including those who do not directly identify with other members.
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Our efforts have resulted in numerous awards for our positive work environment and culture.
−Removed: Some of the certifications, awards and recognitions recognized or received in 2024 and 2025 include:
−Removed: • Best Places to Work for Women in Korea
−Removed: • Dun & Bradstreet Top Tech Companies to Work for in Israel
−Removed: • Great Places to Work and Best Places to Work based on our employee-validated great workplaces in the following countries, Australia, Brazil, Canada, China, India, Italy, Korea, Singapore, Taiwan, Thailand, the United Kingdom, Vietnam and Raleigh, North Carolina (United States)
−Removed: • Forbes America’s Dream Employers, America’s Best Midsize Employers, America’s Best Employers for Engineers, America’s Best Employers for New Grads
−Removed: • Fortune, America’s Most Innovative Companies
−Removed: • LinkedIn Top Companies, Brazil
+Added: Some of the certifications, awards and recognitions recognized or received include:
+Added: • Best Workplaces for Women, China
+Added: • Best Workplaces for Parents, Korea
+Added: • Great Places to Work and Best Places to Work based on our employee-validated great workplaces in the following countries:
+Added: Australia, Brazil, Canada, China, India, Israel, Korea, Singapore, Taiwan, Thailand, Turkey, Vietnam and Raleigh, North Carolina (United States)
+Added: • Forbes America’s Best Employers:
+Added: Dream Employers, Best Midsize Employers, Best Employers for Engineers, Best Employers for New Grads, Best Employers for Company Culture
+Added: • LinkedIn Top Companies, Israel
• Mercer China, Healthiest Workplace Award for Outstanding Women Care
• Newsweek, America’s Greatest Workplaces:
−Removed: Greatest Workplaces for Mental Wellbeing America
−Removed: News & World Report - Best Companies to Work For and Best Companies to Work For in the Health Care Industry
+Added: Overall, By State (California), Gen Z, Inclusion, Mental Well-Being, Parents & Families
We believe it is imperative to provide a vibrant employee experience and we value our employees’ collective voices.
−Removed: Accordingly, we conduct employee surveys that utilizes a continuous employee listening strategy.to collect employee feedback critical to improving our culture.
−Removed: This listening strategy includes globally managed pulse surveys, employee lifecycle surveys, and a self-service feature to support listening efforts.
+Added: Accordingly, we conduct recurring employee surveys that utilize a continuous employee listening strategy to collect employee feedback critical to improving our culture.
+Added: This includes globally managed pulse surveys, employee lifecycle surveys, and a self-service feature to support listening efforts.
We use what we learn from the surveys to improve the employee experience, including enhancements to our workplaces, focus on employee connections, increased career development opportunities, support for relocated employees, and growth in our recognition programs and experiences.
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We also believe learning should be relevant and actionable as well as rooted in our purpose and values.
−Removed: Develop@Align enables our global employee population to access a diverse portfolio of approximately 1,800 self-directed courses in up to 80 languages.
+Added: develop@Align, our global online learning hub, enables our global employee population to access a diverse portfolio of approximately 2,100 self-directed courses in up to 23 languages.
We also offer a full suite of custom leadership development programs, beginning with aspiring leaders, continuing with managers and directors, and culminating with executive development opportunities.
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self, networks, experience and skills.
−Removed: Since its launch in 2022, over 45% of the population has interacted with Voyage, and there have been over 140,000 visits to the Voyage website.
−Removed: In addition to our navigation site, we annually host two Voyage Set Sail weeks, where we offer experiential learning for individuals and teams utilizing activities that keep professional development front and center in employees’ minds.
+Added: Since its launch in 2022, over 70% of the employee population has interacted with Voyage, and there have been over 164,000 visits to the Voyage website.
+Added: In addition to our navigation site, we annually host a Voyage Set Sail Month, where we offer experiential learning for individuals and teams utilizing activities that keep professional development front and center in employees’ minds.
Compensation and Benefits .
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We are furthermore committed to pay equity practices.
−Removed: We exceed minimum pay requirements for our manufacturing employees and regularly review our pay equity practices globally and locally to address discrepancies.
+Added: We exceed minimum pay requirements for our manufacturing employees and regularly review our pay equity practices globally and locally for compliance with applicable laws and work to address discrepancies identified.
Health, Wellness and Safety .
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We therefore offer a wide variety of robust programs and initiatives designed to promote the overall health and welfare of all our employees and their families.
−Removed: Every year, we sponsor the Month of Wellness, a month dedicated to well-being and a worldwide movement fostering employee health across our organization.
+Added: Every year, we promote a Month of Wellness, a month dedicated to well-being and a worldwide movement fostering employee health across our organization.
Throughout the Month of Wellness, employees participate in a variety of activities such as informational sessions and health fairs and receive useful resources aligned to our wellness pillars - mental resilience, physical well-being and healthy living, social/family connections, and financial wellness.
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Additionally, a primary objective is to prevent injuries and occupational diseases by focusing first and foremost on creating and maintaining safe environments.
−Removed: We have e nvironmental, health, safety and sustainability personnel who are
−Removed: responsible for ensuring health and safety programs and processes are maintained and effective at each of our locations.
−Removed: Major worksites, such as our clear aligner fabrication sites, and large offices have dedicated Environmental Health and Safety (“EHS”) departments which are dedicated to ensuring our health and safety programs are maintained while contributing Best Management Practices and general input to corporate-wide programs.
+Added: We have e nvironmental, health, safety and sustainability personnel who are responsible for ensuring health and safety programs and processes are maintained and effective at each of our locations.
+Added: Major worksites, such as our clear aligner fabrication sites, and large offices have dedicated Environmental Health and Safety (“EHS”) departments dedicated to ensuring our health and safety programs are maintained while contributing Best Management Practices and general input to corporate-wide programs.
Each EHS department is responsible for ensuring all employees at their location are properly trained on various EHS topics and at the appropriate frequencies.
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We actively encourage employees to support charitable organizations by providing opportunities for volunteerism, team building, and donation and matching programs.
−Removed: In 2024 , our employees continued to make us proud through their generosity and dedication, especially during our annual Month of Smiles initiative in October where we encourage them to make a difference individually and as teams through volunteer activities, charitable donations, fundraising, and intentional acts of goodness.
−Removed: In addition, through our Align Foundation, we support organizations whose visions closely align with our mission to improve smiles, supporting and educating teens, and empowering our customers through partnerships with learning institutions and foundations.
+Added: In 2025 , our employees continued to make us proud through their generosity and dedication, especially during our annual Month of Smiles initiative in October where we encouraged them to make a difference individually and as teams through volunteer activities, charitable donations, fundraising, and intentional acts of goodness.
+Added: In addition, through our Align Foundation, we support organizations whose visions closely align with our
+Added: mission to improve smiles, supporting and educating teens, and empowering our customers through partnerships with learning institutions and foundations.
Below are some of our key community initiatives in 2025 :
• Since 2013, we have been a proud supporter of Operation Smile, a global medical nonprofit that has provided hundreds of thousands of free surgeries for people born with cleft lips and cleft palates in low and middle-income countries.
−Removed: For the fourth year, we sponsored Operation Smile’s International Student Leadership Conference, a powerful opportunity for youth in high schools and colleges around the world to develop leadership skills and impact their communities.
−Removed: As part of our 2024 sponsorship, we provided full scholarships for 74 participants and students personally impacted with a cleft condition.
−Removed: In addition, we covered a portion of the conference fee for all students to make this opportunity more accessible for all attendees.
+Added: For a fifth year, we were the title sponsor of Operation Smile’s International Student Leadership Conference, a powerful opportunity for youth in high schools and colleges around the world to develop leadership skills and impact their communities.
+Added: As part of our 2025 sponsorship, we provided scholarships for 90 students, including those born with cleft conditions and those facing financial barriers.
As of December 31, 2025, we had donated approximately $3.4 million to Operation Smile.
−Removed: • As part of Align’s commitment to improving oral health, we partnered with the INCAE Business School as they relaunched the CAHI Jeffe Fellowship in Health and Innovation to improve health services in Latin America.
−Removed: The CAHI Jeffe Fellowship brought together 23 leaders from six Latin American countries and focused on enhancing the quality, accessibility, and affordability of health services through a variety of programs.
+Added: • As part of Align’s commitment to improving oral health, we partnered with the INCAE Business School as part of the CAHI Jeffe Fellowship in Health and Innovation to improve health services in Latin America.
+Added: The CAHI Jeffe Fellowship brought together 19 leaders from nine Latin American countries and focused on enhancing the quality, accessibility, and affordability of health services through a variety of programs.
Align provided scholarships to two leaders from the program who focused on oral health education and expansion of dental health for low-income populations.
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As Title Sponsor of the HERO Program since 2019, we have helped the program reach an estimated 2.87 million children, caregivers, and parents.
−Removed: During America’s ToothFairy’s 2024 fiscal year, which ended June 30th, the HERO Program positively impacted more than 900,000 children and caregivers, including:
−Removed: ◦ More than 600,000 children—33,500 of whom speak a language other than English—who were reached with downloadable resources accessed from AmericasToothFairy.org,
−Removed: ◦ 43,250 children taught with ToothFairy 101 ® Community Education Kits distributed to educators, public health workers, and oral health professionals, and
−Removed: ◦ Nearly 268,000 people who were reached through two sponsored awareness campaigns that included educational materials and social media kits.
+Added: During America’s ToothFairy’s 2025 fiscal year, which ended June 30th, the HERO Program positively impacted 1,082,150 children and caregivers using downloadable resources, which are also available in multiple languages.
+Added: With Align’s support, America’s ToothFairy’s Dental Resource Program (DRP) member clinics provided clinical care to 213,675 children—on average, a 25% increase over 2024.
+Added: ◦ 191,204 children received fluoride varnish, nearly 36% more than in 2024
+Added: ◦ 75% of patients served live at or below the poverty line
+Added: ◦ 44% of children treated live in rural communities where access to care is limited
+Added: ◦ 52% of care was delivered through school-based programs
+Added: ◦ 85% of patients rely on state-funded insurance
We also provide product donations to the dental community to help patients in need of healthy, beautiful smiles.
−Removed: For more information on our charitable and community efforts, please refer to the Corporate Social Responsibility portion of our corporate website located at https://www.aligntech.com/about/corporate_social_responsibility .
+Added: For more information on our charitable and community efforts, please refer to the Corporate Accountability portion of our corporate website located at https://www.aligntech.com/about/corporate_accountability .
Available Information
Our corporate website address is www.aligntech.com , and our investor relations website address is http://investor.aligntech.com .
−Removed: The information on or accessible through either of these websites is not incorporated by reference into this Annual Report on Form 10-K, and the above references to these website URLs are intended to be inactive textual references only.
−Removed: Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, our proxy statement on Schedule 14A for our annual stockholders’ meeting and amendments to reports filed pursuant to Sections 13(a) and 15(d) of the Exchange Act are available, free of charge, on our investor relations website as soon as reasonably practicable after we electronically file or furnish such material with the Securities and Exchange Commission (“SEC”).
+Added: The information on or accessible through either of these websites is not incorporated by reference into this Annual Report on Form 10-K, and all website URLs in this Annual Report on Form 10-K are intended to be inactive textual references only.
+Added: Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, our proxy statements on Schedule 14A for our annual stockholders’ meetings and amendments to reports filed pursuant to Sections 13(a) and 15(d) of the Exchange Act are available, free of charge, on our investor relations website as soon as reasonably practicable after we electronically file with or furnish such material to the Securities and Exchange Commission (“SEC”).
Further, the SEC maintains an internet site ( http://www.sec.gov) that contains reports, proxy and information statements and other information regarding our filings with the SEC.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.