Invisalign® Palatal Expander System

K252931 · Align Technology, Inc. · NXC · Oct 23, 2025 · Dental

Device Facts

• Record ID: K252931
• Device Name: Invisalign® Palatal Expander System
• Applicant: Align Technology, Inc.
• Product Code: NXC · Dental
• Decision Date: Oct 23, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Invisalign® Palatal Expander System is indicated for the orthodontic treatment of malocclusion. The system is used for 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 and during orthodontic or orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.

Device Story

System consists of doctor-prescribed, 3D-printed, removable orthodontic appliances (expanders and holders) and proprietary 3D orthodontic software. Software processes patient scans and doctor prescriptions to generate digital manufacturing files. Device used in clinical settings by dental practitioners. New feature adds optional engagement points (forward or backward facing) to support orthodontic accessories like elastics. Engagement features provide anchor points for treatment plan execution without altering device principle of operation. Appliances manufactured from proprietary thermoplastic polyamide. Benefits include targeted maxillary expansion and holding, with added flexibility for accessory use to address malocclusion.

Clinical Evidence

Bench testing only. Functional and performance testing, including stiffness, retention, and durability, conducted with orthodontic accessories. All testing met acceptance criteria.

Technological Characteristics

Additive manufactured (3D printed) removable orthodontic appliances. Material: proprietary thermoplastic polyamide. Features optional engagement points for orthodontic accessories. Software-driven design based on patient scans.

Indications for Use

Indicated for orthodontic treatment of malocclusion, specifically rapid expansion and holding of skeletal/dental narrow maxilla. Applicable to children/adolescents with primary, mixed, or permanent dentition. In adults, used with surgery or other interventions.

Regulatory Classification

Identification

An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

Predicate Devices

• Invisalign Palatal Expander System (K232887)
• Invisalign System (K252380)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

October 23, 2025

Align Technology, Inc
Ahanitha Ashok
Principal Regulatory Affairs Specialist
2820 Orchard Parkway
San Jose, California 95134

Re: K252931
Trade/Device Name: Invisalign® Palatal Expander System
Regulation Number: 21 CFR 872.5470
Regulation Name: Orthodontic Plastic Bracket
Regulatory Class: Class II
Product Code: NXC, PNN
Dated: October 15, 2025
Received: October 22, 2025

Dear Ahanitha Ashok:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252931 - Ahanitha Ashok
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K252931 - Ahanitha Ashok
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

MICHAEL E. ADJODHA -S

Michael E. Adjodha, MChE, RAC, CQIA
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

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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252931 | |
| Device Name Invisalign Palatal Expander System | |
| Indications for Use (Describe) The Invisalign® Palatal Expander System is indicated for the orthodontic treatment of malocclusion. The system is used for 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 and during orthodontic or orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary. | |
| Type of Use (Select one or both, as applicable) ☑ 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 [e-mail] | |
| "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." | |

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| 510(k) #: K252931 | 510(k) Summary | Prepared on: 2025-10-22 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Align Technology, Inc | |
| Applicant Address | 2820 Orchard Parkway San Jose CA 95134 United States | |
| Applicant Contact Telephone | [phone] | |
| Applicant Contact | Ms. Ahanitha Ashok | |
| Applicant Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Invisalign Palatal Expander System | |
| Common Name | Orthodontic plastic bracket | |
| Classification Name | Aligner, Sequential | |
| Regulation Number | 872.5470 | |
| Product Code(s) | NXC, PNN | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K232887 | Invisalign Palatal Expander System | NXC, PNN |
| K252380 | Invisalign System | NXC, PNN |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The Invisalign® Palatal Expander (IPE) System (subject device) consists of a series of doctor prescribed, additive manufactured (3D Printed), removable orthodontic appliances (Invisalign® Palatal Expanders and Invisalign® Palatal Holders), and proprietary Align internal personnel facing shape generating 3D Orthodontic Software. The IPE System is indicated for the orthodontic treatment of malocclusion. The System is used for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and teeth, palate) with primary, mixed (primary and permanent), or permanent dentition during orthodontic or orthopedic treatment in children or adolescents. In adults, the IPE System is to be used in conjunction with surgery or other interventions when necessary. The proprietary 3D Orthodontic Software creates digital files for IPE System to be manufactured using digital data from the doctor/dental practitioner's prescription and patient scans. This submission adds an optional engagement feature to the existing Invisalign Palatal Expander System. Engagement features support the usage of commercially available orthodontic accessories such as elastics per the doctor's treatment plan for the treatment of malocclusion. This submission adds an optional engagement feature to the existing Invisalign® Palatal Expander System (K232887). The proposed addition of engagement feature to IPE System is similar to the reference device, Invisalign System (K252380). Engagement features are designed to provide an anchor point to support the usage of commercially available orthodontic accessories such as elastics per the doctor's treatment plan for the treatment of malocclusion without altering the principle of operation of the device. The engagement features can be either forward facing or backward facing per the doctor's treatment plan. The IPE System with engagement features are additive manufactured using the same material as the predicate device (proprietary thermoplastic polyamide) and use the same manufacturing process as the predicate device. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |

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The Invisalign® Palatal Expander System is indicated for the orthodontic treatment of malocclusion. The system is used for 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 and during orthodontic or orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.

**Indications for Use Comparison** 21 CFR 807.92(a)(5)

The intended use and indications for use are the same as predicate device, K232887.

**Technological Comparison** 21 CFR 807.92(a)(6)

The subject device and predicate device have the following similarities:

- Same Intended Use
- Same Indications for Use
- Same principles of operation
- Same material, and product performance
- Similar technological characteristics

The difference between the subject device and predicate device is limited to the technological characteristics. The design of the subject device has been modified to add engagement features to support the usage of commercially available orthodontic accessories such as elastics per the doctor's treatment plan for the treatment of malocclusion without altering the principle of operation of the device. The engagement features are manufactured using the same material and same manufacturing process as the predicate device. The proposed engagement features technological characteristics are similar to the reference device, Invisalign System (K252380). The verification and validation testing results demonstrated that the technological difference of the addition of engagement features does not raise any safety and effectiveness questions, and the subject device is substantially equivalent to the predicate device, K232887.

**Non-Clinical and/or Clinical Tests Summary & Conclusions** 21 CFR 807.92(b)

The subject device, Invisalign® Palatal Expander System underwent a complete set of functional and performance testing, including stiffness, retention, and durability testing with additional orthodontic accessories, using similar test methods as the predicate and reference device. All testing passed acceptance criteria and demonstrated the device modification does not affect the safety and effectiveness of Invisalign® Palatal Expander System. The results conclude that the difference in technological characteristics between the subject device and its predicate devices does not raise different questions of safety or effectiveness. Thus, the subject device is found to be substantially equivalent to the legally marketed predicate device, Invisalign Palatal Expander System (K232887).