Align Technology Inc
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 14
- Inspections
- 3
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1017-2023 | Class II | Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System | December 5, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252931 | Invisalign® Palatal Expander System | October 23, 2025 |
| K252870 | Invisalign Specifix Attachment System | October 9, 2025 |
| K252380 | Invisalign System | August 29, 2025 |
| K240573 | iTero Lumina Pro | August 16, 2024 |
| K241412 | Invisalign System | June 18, 2024 |
| K232887 | Invisalign Palatal Expander System | December 15, 2023 |
| K232233 | Invisalign System with Mandibular Advancement Featuring Occlusal Blocks | September 26, 2023 |
| K222894 | Invisalign System, Pre-Formed Attachment System | December 22, 2022 |
| K220287 | Invisalign System | April 7, 2022 |
| K193659 | iTero Element 5D | March 20, 2020 |
| K181739 | Invisalign System with Mandibular Advancement Feature | October 26, 2018 |
| K143630 | Invisalign System | November 18, 2015 |
| K081960 | INVISALIGN SYSTEM | December 17, 2008 |
| K981095 | ALIGN SYSTEM | September 8, 1998 |