Align Technology, Inc.
Medical device manufacturer in Petach Tikva, IL.
15510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261847 | iTero Lumina ProNTK · Special | 07/02/2026SE |
| K252931 | Invisalign® Palatal Expander SystemNXC · Special | 10/23/2025SE |
| K252870 | Invisalign Specifix Attachment SystemNXC · Special | 10/09/2025SE |
| K252380 | Invisalign SystemNXC · Special | 08/29/2025SE |
| K240573 | iTero Lumina ProNTK · Traditional | 08/16/2024SE |
| K241412 | Invisalign SystemNXC · Special | 06/18/2024SE |
| K232887 | Invisalign Palatal Expander SystemNXC · Traditional | 12/15/2023SE |
| K232233 | Invisalign System with Mandibular Advancement Featuring Occlusal BlocksNXC · Traditional | 09/26/2023SE |
| K222894 | Invisalign System, Pre-Formed Attachment SystemNXC · Traditional | 12/22/2022SE |
| K220287 | Invisalign SystemNXC · Special | 04/07/2022SE |
| K193659 | iTero Element 5DNTK · Traditional | 03/20/2020SE |
| K181739 | Invisalign System with Mandibular Advancement FeatureNXC · Traditional | 10/26/2018SE |
| K143630 | Invisalign SystemNXC · Traditional | 11/18/2015SE |
| K081960 | Invisalign SystemNXC · Traditional | 12/17/2008SE |
| K981095 | Align SystemNXC · Traditional | 09/08/1998SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1017-2023 Class II | Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign…3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may… | 12/05/2022Completed |