Invisalign System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 7, 2022 Align Technology, Inc. Shweta Daga Director, Regulatory Affairs 2820 Orchard Parkway San Jose, California 95134 Re: K220287 Trade/Device Name: Invisalign System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: March 10, 2022 Received: March 11, 2022 Dear Shweta Daga: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220287 Device Name Invisalign System Indications for Use (Describe) The Invisalign System is intended for the orthodontic treatment of malocclusion. **Type of Use (Select one or both, as applicable)** | <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart G) | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| > Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) SUMMARY # Align Technology's Invisalign System # General Information | 510(k) Sponsor | Align Technology, Inc. | |-------------------------|-----------------------------------------------------------------------------| | Address | 2820 Orchard Parkway<br>San Jose, CA 95134 | | FDA Registration Number | 2953749 | | Contact Person | Shweta Daga<br>Director, Regulatory Affairs<br>Align Technology, Inc. | | Contact Information | Email: sdaga@aligntech.com<br>Phone: +1 408-470-1000<br>Fax: +1408-470-1010 | | Date Prepared | Jan 31, 2022 | ## Name of Device and Name/Address of Sponsor | Name of Device | Invisalign System | |-------------------------|----------------------------------------------------------------------| | Name/Address of Sponsor | Align Technology, Inc.<br>2820 Orchard Parkway<br>San Jose, CA 95134 | | Trade/Proprietary Name | Invisalign System | | Common Name | Aligner, Sequential | | Classification Name | Orthodontic Plastic Bracket | # Predicate Device | Name of Device | Invisalign System with Mandibular Advancement Feature (MAF) | |-------------------------|----------------------------------------------------------------------| | Name/Address of Sponsor | Align Technology, Inc.<br>2820 Orchard Parkway<br>San Jose, CA 95134 | | Trade/Proprietary Name | Invisalign System with Mandibular Advancement Feature | | Common Name | Aligner, Sequential | | Classification Name | Orthodontic Plastic Bracket | {4}------------------------------------------------ ## Purpose of the Special 510(k) notice. The purpose of this Special 510(k) notice is to request clearance for proposed changes related to labeling material which include the Doctor's Instructions for Use (IFU), and Patient's IFU, with minor changes and clarifications made based on post-market data. Additionally, this Special 510(k) premarket notification describes all non-significant changes implemented through documentation since the last 510(k) clearance. #### Intended Use The Invisalign System is indicated for the orthodontic treatment of malocclusion. ## Device Description The Invisalign System (subject device) consists of removable orthodontic appliances (aligners), proprietary 3D software and attachment template. The system consists of a series of doctor prescribed, customized, thin, clear plastic aligners that gently move the patient's teeth in small increments from their original state to a more optimal, treated state to address malocclusion. The optional mandibular advancement feature positions patients iaw forward to address skeletal malocclusion. The system is used in patients with primary, mixed, and permanent dentition. The Invisalign System is intended for treating dental and skeletal malocclusion in patients with Class I, II and III including Antoro-Posterior (A-P), vertical (open bite, transverse (narrow arch or jaw, crossbite), or inter-arch (spacing and crowding) correction at all severity levels. In some cases, surgical intervention, or addition of other appliances in addition treatment may be needed at the doctor's discretion. The Invisalign System aligners consist of a series of customized orthodontic devices made from proprietary thermoformed polyurethane sheeting material. The first device in the series matches the patient's dentition in its current state and then each subsequent aligner stage has the shape of the dentition shifted gradually toward the final desired position. The aligners can accommodate use of tooth attachments and elastics (through use of precision cut outs or buttons or power arms). The system can also be ordered with additional aligner features such as precision cut outs, bite ramps, compliance indicators, and mandibular advancement features (MAF). MAF is also referred to as precision wings and is prescribed by the dental practitioner to position the lower jaw forward during correction of skeletal malocclusion. The subject device system of this Special 510(k), referred to as the Invisalign System, is a modification to the predicate device the Invisalign System with Mandibular Advancement Feature (MAF) (K181739, cleared on Oct 26, 2018) and is inclusive of both standard aligners and aligners with mandibular advancement feature. The proprietary ClinCheck (CC) 3-D software is inclusive of both dental practitioner-facing functions and internal Align personnel-facing functions. The Align personnel-facing functions are termed 'Treat' internally. This internal facing software enables Align's computer-aided design (CAD) designers to create a treatment plan based on a doctor's prescription and inputs (e.g., dental scans). The treatment plans created using the Align personnel-facing software are then reviewed and approved by doctors before the aligners are manufactured. The doctors' reviews and approvals are exchanged via ClinCheck software (dental practitioner-facing software). Once the treatment plan is approved by the dental practitioner, the information is sent to the manufacturing facility for creation of the aligners. When attachments are prescribed as part of the treatment plan, a disposable template is provided to assist the dental practitioner in positioning and forming the attachments from dental composite (sold separately). Attachment templates are disposable polyurethane appliances which match the patient's existing dentition and include wells for the placement of dental composite. During the first {5}------------------------------------------------ visit, the dental practitioner uses the template in bonding dental composite to the tooth surface to create attachments on the teeth. These attachments help create forces on the tooth which can assist in aligner retention or optimized aligner force system for tooth movement. All these components and features were available with the predicate device. #### Comparison with Predicate Device Proposed modified device and predicate device have the same indications for use, intended use, technological characteristics, and principle of operation. The material of the Modified Device is identical to the Predicate Device. The differences between the modified device and the predicate device are minor labeling updates which do not raise any questions regarding safety and effectiveness. In accordance with 21 CFR 807.92(a)(6) a summary of the technological characteristics' comparison of the proposed modified device to the predicate Device is provided below. #### Technological Characteristics comparison with the Predicate Device The Invisalign System (subject device) has no proposed changes to its technological characteristics. The proposed labeling changes do not alter any technological characteristics and do not impact the current safety and effectiveness profile of the Invisalign System. The Invisalign System with minor modifications implemented to date through documentation to file has similar technological characteristics as the predicate device - Invisalign System with Mandibular Advancement Feature (cleared in K181739). The material and mode of action are unchanged and no new aligner features have been introduced. | Comparison<br>Criteria | Subject/ Modified Device | Predicate/ Existing Device<br>(K181739) | Comparison<br>Assessment | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Indications for<br>Use | The Invisalign System is<br>intended for the orthodontic<br>treatment of malocclusion. | The Invisalign System is<br>intended for the orthodontic<br>treatment of malocclusion. | Same as predicate<br>device | | In Use Duration | Aligners are worn for<br>approximately 1-2 weeks of 20-<br>22 hours of wear per day, after<br>which it is replaced by the next<br>stage aligners. This is repeated<br>for duration as prescribed by<br>the Dental Practitioner. | Aligners are worn for<br>approximately 1-2 weeks of 20-<br>22 hours of wear per day, after<br>which it is replaced by the next<br>stage aligners. This is repeated<br>for duration as prescribed by<br>the Dental Practitioner. | Same as predicate<br>device | | Patient<br>Population | Children, Adolescents and<br>Adults | Pediatrics and Adults | Same as predicate<br>device | | Use Location | Dental intraoral Devices | Dental intraoral Devices | Same as predicate<br>device | | OTC or<br>Prescription (Rx)<br>Device | Rx only | Rx only | Same as predicate<br>device | {6}------------------------------------------------ | Comparison<br>Criteria | Subject/ Modified Device | Predicate/ Existing Device<br>(K181739) | Comparison<br>Assessment | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Design | | | Operating<br>Principle | Aligners: Sequential aligners<br>apply continuous gentle force to<br>the teeth and/or position<br>mandible forward.<br>3D Software: Produces 3D-<br>model file of the PVS<br>impression or the digital scan.<br>Identifies the individual teeth<br>that require treatment (i.e.,<br>repositioning). Creates a<br>treatment plan (i.e., 3-D models<br>that represent the treatment<br>plan) which is reviewed by the<br>treating dental practitioner using<br>ClinCheck's doctor facing<br>function to reject or request<br>modifications to the set-up prior<br>to approval. | Aligners: Sequential aligners<br>apply continuous gentle force to<br>the teeth and position mandible<br>forward<br>3D Software: Produces 3D-<br>model file of the PVS<br>impression or the digital scan.<br>Identifies the individual teeth<br>that require treatment (i.e.,<br>repositioning). Creates a<br>treatment plan (i.e., 3-D models<br>that represent the treatment<br>plan) which is reviewed by the<br>treating dental practitioner using<br>ClinCheck's doctor facing<br>function to reject or request<br>modifications to the set-up prior<br>to approval. | Same as predicate<br>device<br>Note, mandible<br>advancement feature<br>such as precision<br>wings is an optional<br>feature offered<br>through the predicate<br>device. | | Materials | Thermoplastic polymer | Thermoplastic polymer | Same as predicate<br>device | | Lower Jaw<br>Adjustment<br>Mechanism | Invisalign System aligners with<br>mandibular advancement<br>feature (MAF) such as<br>enhanced precision wings with<br>a curved design.<br>For Invisalign system with<br>standard aligners this is not<br>applicable. | Invisalign System Mandibular<br>Advancement Feature wings<br>such as enhanced precision<br>wings with a curved design | Same as predicate<br>device<br>Note, mandible<br>advancement feature<br>such as precision<br>wings is an optional<br>feature offered<br>through predicate<br>device. | # Performance Data There are no proposed design changes in the scope of this pre-market notification. The proposed labelling changes do not trigger any performance testing as the changes are minor clarifications and additions that do not impact the current safety and effectiveness profile of the Invisalign System. No animal or clinical testing was required to validate these labeling modifications. #### Substantial Equivalence The Invisalign System (Subject Device) and the previously cleared predicate Invisalign System with Mandibular Advancement are similar in that they have: - same intended use, - . same indications for use, - . same principles of operation, and - same technological characteristics. {7}------------------------------------------------ The primary change introduced to the Invisalign System through the Special 510(k) submission is proposed labeling updates to the doctor and patient instruction for use. There are no proposed design changes as part of this submission. # Conclusion Align Technology's Invisalign System has the same intended use and indications for use as the previously cleared Invisalign System with Mandibular Advancement Feature (MAF) (K181739). In addition, the Invisalign System has the same technological characteristics, and principles of operation as its predicate. The minor labeling differences between the Invisalign System and its predicate device do not raise new questions of safety or efficacy. Thus, the Invisalign System is substantially equivalent.