# Align Technology, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 16 (1998–2026): 16 510(k) clearances
- Names in FDA's records: Align Technology, Inc. (12); Align Technology (2); Align Technology , Ltd. (2)
- Product codes: NXC (12), NTK (3), PNN (1)
- 510(k) review time since 2016: median 63 days, against 111 for FDA's reviews in the same codes and years (9 of 10 faster)
- Predicates its devices cite: 17 (14 its own); citations of its devices by later devices: 39 (14 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Duerr Dental AG: 1 (https://510kreport.com/company/duerr-dental)
- Tp Laboratories, Inc.: 1 (https://510kreport.com/company/tp-laboratories)
- Dentauraum, Inc.: 1 (https://510kreport.com/company/dentauraum)

## Firms that cite its devices most
- Dentsply International, Inc.: 2 (https://510kreport.com/company/dentsply-international)
- Clearcorrect, LLC: 2 (https://510kreport.com/company/clearcorrect)
- Tns Co., Ltd.: 2 (https://510kreport.com/company/tns)
- Sybron Dental Specialties, Inc.: 1 (https://510kreport.com/company/sybron-dental-specialties)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)
- Smile Development Corp: 1 (https://510kreport.com/company/smile-development)
- Ensmile Pvt, Ltd.: 1 (https://510kreport.com/company/ensmile-pvt)
- Dror Orthodesign, Ltd.: 1 (https://510kreport.com/company/dror-orthodesign)

## Its most-cited devices
- K981095: Align System (1998), cited by 9
- K081960: Invisalign System (2008), cited by 9
- K220287: Invisalign System (2022), cited by 6
- K143630: Invisalign System (2015), cited by 5
- K181739: Invisalign System with Mandibular Advancement Feature (2018), cited by 3
- K232233: Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (2023), cited by 1

## Recent decisions
- K262196: Invisalign System (Sep 25, 2026)
- K261847: iTero Lumina™ Pro (Jul 2, 2026)
- K252931: Invisalign® Palatal Expander System (Oct 23, 2025)
- K252870: Invisalign Specifix Attachment System (Oct 9, 2025)
- K252380: Invisalign System (Aug 29, 2025)
- K240573: iTero Lumina™ Pro (Aug 16, 2024)
- K241412: Invisalign System (Jun 18, 2024)
- K232887: Invisalign Palatal Expander System (Dec 15, 2023)

Source page: https://510kreport.com/company/align-technology