Align Technology, Inc.
FDA 510(k) & PMA Approved Devices — 10 products
Total Devices10
Categories2
Latest FDA decision2025-10-23
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K252931 | Invisalign® Palatal Expander System | NXC | 2025-10-23 | View |
| 510(k) | K252870 | Invisalign Specifix Attachment System | NXC | 2025-10-09 | View |
| 510(k) | K252380 | Invisalign System | NXC | 2025-08-29 | View |
| 510(k) | K241412 | Invisalign System | NXC | 2024-06-18 | View |
| 510(k) | K232887 | Invisalign Palatal Expander System | NXC | 2023-12-15 | View |
| 510(k) | K232233 | Invisalign System with Mandibular Advancement Featuring Occlusal Blocks | NXC | 2023-09-26 | View |
| 510(k) | K222894 | Invisalign System, Pre-Formed Attachment System | NXC | 2022-12-22 | View |
| 510(k) | K220287 | Invisalign System | NXC | 2022-04-07 | View |
| 510(k) | K193659 | iTero Element 5D | NTK | 2020-03-20 | View |
| 510(k) | K181739 | Invisalign System with Mandibular Advancement Feature | NXC | 2018-10-26 | View |
No matching devices.