Align Technology, Inc. (‘Align’), a global medical device company, primarily engages in the design, manufacture and marketing of Invisalign clear aligners for the treatment of malocclusions, or the misalignment of teeth, by orthodontists and general dental practitioners (‘GPs’), Vivera retainers for retention, iTero intraoral scanners and services for dentistry, and exocad computer-aided design and computer-aided manufacturing (‘CAD/CAM’) software for dental laboratories and dental practitioners...
Align Technology, Inc. (‘Align’), a global medical device company, primarily engages in the design, manufacture and marketing of Invisalign clear aligners for the treatment of malocclusions, or the misalignment of teeth, by orthodontists and general dental practitioners (‘GPs’), Vivera retainers for retention, iTero intraoral scanners and services for dentistry, and exocad computer-aided design and computer-aided manufacturing (‘CAD/CAM’) software for dental laboratories and dental practitioners.
The company sells the majority of its products and services directly through a dedicated and specialized sales force to its customers: orthodontists, GPs, including prosthodontists, periodontists, oral surgeons, and dental laboratories. It also sells through sales agents and distributors in certain countries. In addition, it sells directly to Dental Support Organizations (‘DSOs’), which contract with dental practices to provide critical business management and support, including non-clinical operations. The company also sells its products to dental laboratories, which use its products to manufacture or customize their own products for licensed dentists. Furthermore, it markets and sells doctor and consumer accessory products complementary to its 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’). Depending on the product, the company’s Invisalign Accessory Products are sold through a variety of channels, including online through large e-commerce websites, its doctor portal, and in-store through large retailers and pharmacy stores.
The company’s clear aligners are sold under the Invisalign brand name. The company’s Invisalign System is intended mainly for the treatment of malocclusions and is designed to help dental professionals achieve the clinical outcomes they expect and the results patients desire. As of December 31, 2024, over 19 million people worldwide have been treated with the Invisalign System. In order to provide Invisalign treatment to their patients, orthodontists and GPs must initially complete an Invisalign training course. The company’s iTero intraoral scanners are used by dental professionals, labs, and service providers for restorative and orthodontic digital procedures, as well as Invisalign case submissions. The company’s 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.
The company has two operating segments: Clear Aligner and Imaging Systems and CAD/CAM Services (‘Systems and Services’). For the year ended December 31, 2024, Clear Aligner net revenues represented approximately 81% of worldwide net revenues, while Systems and Services net revenues represented the remaining 19%.
Products, Services and Technologies
Align Digital Platform
The company strives 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. The Align Digital Platform is the foundation of its 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 its doctor-centered treatment model. The Align 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 – doctors, labs, patients, and consumers. At the center of the Align Digital Platform are Invisalign clear aligners, iTero intraoral scanners, and exocad CAD/CAM software.
The Align Digital Platform utilizes the Align Digital Workflow to enable an end-to-end digital treatment experience and generate interconnected workflows and treatment solutions, that includes the following key components:
Connect: The initial stage of the platform drives consumer demand and connects potential patients to the company’s websites and the websites of Invisalign providers. Some of the tools that support this stage are Invisalign.com, the Invisalign SmileView tool, My Invisalign app, Doctor Locator, Invisalign Practice App, and Invisalign Virtual Appointment.
Scan: 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. Visualization of their potential smiles helps patients understand the benefits of treatment and increase patient conversion. 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 tool, iTero Element 5D auto-upload feature, iTero Scan Report, and iTero-exocad Connector.
Diagnose: Doctors can access and use tools that support diagnosis of a patient’s oral health and develop an appropriate treatment pathway. The Align Digital Platform facilitates the doctor-patient conversation through education regarding clinical needs and setting expectations. Some of the tools that support this stage include Align Oral Health Suite, iTero intraoral scanners, including those with NIRI technology (Near Infra-Red Imaging), iTero TimeLapse technology, and iTero Occlusogram.
Plan: Doctors digitally visualize and plan orthodontic and restorative treatments. Orthodontists and GPs can use its 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. 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, iTero Design Suite, exocad Dental CAD software, and exocad Dental CAD 3.2 Elefsina software.
Treat: During this stage, doctors treat their patients with the company’s Invisalign clear aligners and may offer teeth whitening using the Invisalign Professional Whitening System. The Invisalign Palatal Expander System and the Invisalign System with mandibular advancement featuring enhanced precision wings are additional products that support patient treatment.
Monitor: 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. Some of the tools that support this stage include Invisalign Virtual Care AI, My Invisalign app, Invisalign Doctor Site, Invisalign Practice App, Invisalign Progress Assessment, and iTero scanners.
Retain: Following completion of their orthodontic treatment, patients can retain the final position of their teeth using Vivera retainers.
In 2024, the company launched several new products and technologies that further enhance the Align Digital Platform, including the iTero Lumina intraoral scanner, iTero Multi-Direct Capture technology, ClinCheck Smile Video, iTero Design Suite, Invisalign Smile Architect with treatment planning software with Multiple Treatment Plans, Invisalign Outcome Simulator with Multiple Treatment Simulation, and Align Oral Health Suite with new comparison tools.
Clear Aligner Segment
Malocclusion and Traditional Orthodontic Treatment
Malocclusion is one of the most prevalent clinical dental conditions in the world, affecting approximately 60% to 75% of the global population.
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. Of the 22 million cases started each year, it estimates that almost all can be treated using the company’s Invisalign System, yet its share of the 22 million case starts through orthodontists is approximately 10% globally. The company’s business strategy remains focused on increasing its share of the existing market of orthodontic case starts compared to brackets and wires, especially among teens, and expanding the market for digital orthodontics, especially among adults. By training more doctors, including GPs as well as orthodontists, increasing utilization of existing doctors using its 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, the company is helping drive adoption of digital orthodontics and restorative dentistry globally.
The Invisalign System
The Invisalign System is a proprietary method for treating malocclusion based on a proprietary computer-simulated virtual treatment plan and a series of doctor-prescribed, custom manufactured, clear polymer removable aligners. The company received 510(k) clearance from the U.S. Food and Drug Administration (‘FDA’) to market the Invisalign System in 1998. The Invisalign System offers a range of treatment options, specialized services, and access to proprietary software for treatment visualization, and consists of the following phases: diagnosis and transmission of treatment data; computer-simulated treatment plan; treatment plan review and approval by an Invisalign-trained doctor; manufacture of custom clear aligners; and shipment to the dental professional and patient clear aligner wear.
Clear Aligner Products
The company offers the Invisalign System in a variety of treatment packages designed to correspond with the case-by-case treatment needs of its doctors and their patients, and also designed on nonclinical needs. Most of the company’s Invisalign System products provide dental professionals with the option to order additional clear aligners if the patient’s treatment progress or needs deviate from the original treatment plan.
Comprehensive Products - Invisalign Treatment Options
Invisalign Comprehensive Packages: 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. 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. These packages include Invisalign Comprehensive, Invisalign First Phase 1, and Invisalign First Comprehensive Phase 2.
Invisalign First Phase 1 and Invisalign First Comprehensive Phase 2 Packages: The Invisalign First Phase 1 Package is designed specifically for younger patients, generally between the ages of six and ten, who frequently have a mixture of primary/baby and permanent teeth. Invisalign First Phase 1 treatment provides early interceptive orthodontic treatment, traditionally done through arch expansion or partial metal braces, before all permanent teeth have erupted. Invisalign First Phase 1 clear aligners are designed specifically to address a wide range of younger patients’ malocclusions, including shorter clinical crowns, management of erupting dentition, and predictable dental arch expansion. The company’s Invisalign First Comprehensive Phase 2 Package complements Invisalign First Phase 1 and is generally consistent with its Invisalign Comprehensive Package. After a patient completes Invisalign First Phase 1, doctors have the option to purchase a Comprehensive Phase 2 Package for that same patient.
In the first quarter of 2023, the company launched the Invisalign Comprehensive 3in3 product. 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.
Non-Comprehensive Products - Invisalign Treatment Options:
Invisalign Non-comprehensive Packages: The company offers a variety of lower-priced treatment packages for less complex orthodontic cases, non-comprehensive relapse cases, or teeth straightening prior to restorative or cosmetic treatments, such as veneers. These treatment packages include Invisalign Express, Invisalign Lite, and Invisalign Moderate.
Invisalign Doctor Subscription Program (‘DSP’) is the company’s monthly subscription-based clear aligner program, which includes retainers and low-stage ‘touch-up’ clear aligner treatment. DSP is available in North America, Latin America, and certain countries in Europe.
Invisalign Go Packages: In various markets, the company also offers Invisalign Go, Invisalign Go 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. These packages include case assessment support, simplified ClinCheck treatment plans, and a progress assessment feature for case monitoring.
Non-Case Products:
The Comprehensive and Non-Comprehensive clear aligner packages are distributed in cases, meaning that all the sets of clear aligners required for all the stages of a doctor-approved treatment plan are delivered in a case. The company also sells non-case products. 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.
Retention: The company offers 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. 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. In select markets, the company also offers single set retainers.
Invisalign Professional Whitening System: Additionally, the company offers a professional whitening system using Ultradent’s Opalescence PF whitening system with Invisalign clear aligners or Vivera retainers.
New Products/Feature Enhancement
Invisalign Palatal Expander System: In December 2023, the company received 510(k) clearance in the United States for the Invisalign Palatal Expanders. 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. 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. Each direct 3D printed device is customized to the patient’s unique anatomy based on an iTero intraoral digital scan. A palatal expansion treatment plan and device design are then developed using the company’s proprietary orthodontic software. The Invisalign Palatal Expander is the company’s first direct 3D printed orthodontic device. 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. 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. The Invisalign Palatal Expander System is expected to be commercially available in additional markets, pending regulatory approvals.
In January 2024, the company completed the acquisition of Cubicure GmbH (‘Cubicure’), a company that develops, produces, and distributes innovative materials, equipment, and processes for novel 3D printing solutions. Direct fabrication offers the transformative potential of design flexibility that goes beyond what the current thermoforming technology allows, that may perform even better than its existing ones and address unmet market needs. The company expects to pilot its first devices on this platform with 3D printed retainers in the first half of 2025.
Smart Technology: SmartTrack, SmartForce, and SmartStage
Smart technology is applied in the development of Invisalign treatments and leads to more precise control of individual and multiple tooth movements. The company uses a force-driven system in its Invisalign clear aligners such that the next clear aligner is shaped so that when inserted, the clear aligner stretches and applies the desired force to the surface of the tooth, resulting in the desired tooth movement. Smart technology allows the company to find the right thickness, the right elasticity, and the right force application over a period of time. Smart technology includes the use of SmartTrack, SmartForce, and SmartStage Technology.
SmartTrack Material: SmartTrack clear aligner material is a patented, custom-engineered Invisalign clear aligner material that provides gentle, more constant force to improve control of tooth movements. Conventional clear aligner materials relax and lose a substantial percentage of the force applied in the initial days of wear. SmartTrack material maintains more constant force over a longer period of time. The flexible SmartTrack material also more precisely conforms to tooth morphology, attachments, and interproximal spaces to improve control of tooth movement throughout treatment.
SmartForce Attachments: SmartForce attachments are small tooth-colored shapes that attach to teeth before or during Invisalign treatment. Invisalign clear aligners fit smoothly and tightly around the attachments and give the clear aligners something to gently push on. SmartForce attachments make complex tooth movements possible without braces by helping clear aligners apply the right amount of force in the right direction.
SmartStage Technology: SmartStage is an advanced algorithm that determines the optimal path of tooth movement and the shape of the clear aligner at every stage of an Invisalign treatment. The programming determines tooth movement in a certain sequence, at the right time, to achieve optimal outcomes with greater predictability and fewer undesirable interferences.
Systems and Services Segment
Intraoral scanning is a rapidly evolving technology substantially impacting the practice of dentistry. By enabling the dental practitioner to create a 3D image (digital scan) of a patient’s teeth using a handheld intraoral scanner, digital scanning is faster, more efficient, precise, and comfortable for patients. Beginning patient care with the early use of the company’s iTero intraoral scanners and combining the results with digital workflows designed to assist doctors and patients visualize and evaluate various treatment options with detailed imagery and CAD/CAM solutions helps patients decide to undergo treatment and improve treatment outcomes and satisfaction. The accuracy of digitally scanned models substantially reduces the rate of restoration ‘remakes,’ which results in patients being recalled to dental offices less often and experiencing shorter treatment times for the restoration work because fewer procedures are required after teeth are aligned and spaced optimally, increasing overall patient satisfaction. Digital models also reduce the carbon footprint associated with the shipping of the materials used to create PVS impressions, the shipping of those impressions, and their disposal. Moreover, the digital model file can be used for various procedures and services, including fabrication of physical dental models for use by labs to create restorative units, such as veneers, inlays, onlays, crowns, bridges, and implant abutments; digital records storage; aid to caries detection; orthodontic diagnosis; orthodontic retainers and appliances; and Invisalign digital impression submission.
iTero Scanner: 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. 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 the company’s 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.
The company’s 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. NIRI technology, included in its iTero Element 5D and 5D Plus Imaging Systems, aids in the detection and monitoring of interproximal caries above the gingiva in real time, without using harmful radiation. In October 2021, the findings of a clinical study sponsored by the company 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 the detection of interproximal lesions, without the use of harmful radiation. The company received 510(k) clearance in the United States for the caries detection feature of the iTero Element 5D in 2020. 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 models, seamless scanning with reduced processing time, artificial intelligence (‘AI’)-based features, and, in certain models, NIRI technology.
The company’s iTero Element scanners are offered in a number of software configurations, such as Ortho Comprehensive, Restorative Comprehensive, and Restorative Foundation. These software packages are included in the price of the scanner and have a service period of 1 to 5 years. They enable various orthodontic and restorative workflows, as well as provide other applications, including Invisalign Outcome Simulator, Invisalign Case Assessment tool, Invisalign Progress Assessment tool, and iTero TimeLapse technology. The company’s iTero software is designed for orthodontists for digital records storage, orthodontic diagnosis, and for the fabrication of printed models and retainers. The company’s 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 its iTero-exocad Connector.
In January 2024, the company launched the iTero Lumina intraoral scanner. The iTero Lumina intraoral scanner is designed with iTero Multi-Direct Capture technology that quickly, easily, and accurately captures more data while delivering exceptional scan quality and photorealistic images that remove the need for intraoral photos. iTero Multi-Direct Capture replaces the confocal imaging technology in earlier intraoral scanner models. It has a wider field of capture and multi-angled scanning that enables simultaneous capture from multiple angles. 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. It has a 50% smaller and 45% lighter wand (as compared to the iTero Element 5D imaging system wand, excluding the wand cable), which is expected to be especially beneficial for kids and teen patients. The iTero Lumina scanner has photorealistic scans, which enable high-quality clinical decisions the same way intraoral photos do, and its advanced software enables scanning at two times the speed.
Invisalign Outcome Simulator: 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. 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: The Invisalign Progress Assessment tool provides the ability to compare a patient’s new scan with a specific stage of their ClinCheck treatment plan, allowing doctors to visually assess and communicate Invisalign treatment progress with an easy-to-read, color-coded, tooth movement report.
iTero TimeLapse Technology: The company’s iTero TimeLapse technology allows doctors or practitioners to compare a patient’s historic 3D scans to the present-day scan, enabling clinicians to identify and measure orthodontic movement, tooth wear, and gingival recession. This highlights areas of diagnostic interest to dental professionals and helps foster a proactive conversation with the patient regarding potential restorative or orthodontic solutions.
Align Oral Health Suite: The Align Oral Health Suite is a digital interface designed to enhance dental consultations and drive patient acceptance of dental treatment. 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. 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.
CAD/CAM Services: The company’s exocad CAD/CAM software platform addresses restorative needs in an end-to-end digital platform workflow to facilitate ortho-restorative and comprehensive dentistry. The platform provides doctors and dental labs with digital clinical solutions that aid GPs and dental labs in planning and delivering restorative dental treatments, adding restorative functionality to the company’s comprehensive digital platform to deliver digital ortho-restorative workflows and interdisciplinary dentistry. The company’s exocad software is licensed and sold separately.
Business Strategy
The company’s strategy is to revolutionize orthodontic and restorative dentistry through digital treatment planning and implementation using its Align Digital Platform, an integrated suite of proprietary technologies and services designed to deliver a seamless, end-to-end solution for patients, consumers, orthodontists, GPs, and lab partners. The company strives to achieve its strategy through key objectives made possible with the proprietary technologies and services of the Align Digital Platform to establish: 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; its intraoral scanners as the preferred scanning technology for digital dental scans; and its exocad CAD/CAM software as the dental restorative solution of choice for dental labs.
The company’s strategies are International Expansion; treating the general 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; integrating consumer marketing strategy that includes television, media, social networking, and event marketing, as well as strategic alliances with professional sports teams, and educating patients on treatment options and directing them to high-volume Invisalign trained doctors; and continuing to innovate and increase product applicability and predictability to address a wide range of cases.
Sales and Marketing
The company’s 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. The iTero scanner is an important component of the customer experience and is central to a digital approach, as well as overall customer utilization of Invisalign clear aligners. In each region, the company has direct sales, marketing, and support organizations, which include quota carrying sales representatives, sales management, and sales administration. The company also has distribution partners in certain markets. The company’s 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 its focus and effectiveness on both. The company continues to expand in existing markets through targeted investments in sales resources, professional marketing, and education programs. Additionally, the company’s consumer marketing programs are designed to create awareness and educate consumers on the benefits of Invisalign treatment and Vivera retainers, including where they can find trained doctors to provide treatment. The company provides training, marketing, and clinical support to orthodontists and GPs. As of December 31, 2024, the company had approximately 130,370 active Invisalign-trained doctors.
Intellectual Property
As of December 31, 2024, the company had 1,000 active U.S. patents, 1,063 active foreign patents, and 1,012 pending global patent applications. The company’s active U.S. patents expire between 2025 and 2043.
Seasonal Fluctuations
General economic conditions impact the company’s business and financial results, and it has historically experienced seasonal trends within its two operating segments, customer channels, and the geographic locations that it serves. 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 (year ended December 31, 2024). 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. Conversely, many GPs are on vacation during this time and therefore tend to start fewer cases. For the company’s Systems and Services segment, capital equipment sales are often stronger in the fourth calendar quarter. However, many of these typical seasonal patterns have been impacted by changes in foreign exchange rates, military conflicts, inflation, and other macroeconomic challenges.
Government Regulations
The company’s quality system is required to be in compliance with the Quality System regulations enforced by the FDA, and similar regulations of other worldwide regulatory authorities. The company is certified to ISO 13485:2016, an internationally recognized standard for medical device quality.
With regard to premarket authorization in the United States, many of the company’s products are classified as medical devices under the U.S. Food, Drug, and Cosmetic Act (‘FD&C Act’). Within the EU, its products are subject to the requirements defined by the Medical Device Regulation EU 2017/745, which replaced the Medical Device Directive 93/42/EEC with a final transition date of May 26, 2021. Similar market access regulations exist in Brazil, China, Japan, and other countries. The company’s QMS is routinely audited by certification bodies, as well as country regulators, for compliance with applicable regulations.
History
Align Technology, Inc. was founded in 1997. The company was incorporated in Delaware in 1997.
