Invisalign System
Aligner, Sequential
Align Technology, Inc.
The following data is part of a premarket notification filed by Align Technology, Inc. with the FDA for Invisalign System.
Pre-market Notification Details
| Device ID | K220287 |
| 510k Number | K220287 |
| Device Name: | Invisalign System |
| Classification | Aligner, Sequential |
| Applicant | Align Technology, Inc. 2820 Orchard Parkway San Jose, CA 95134 |
| Contact | Shweta Daga |
| Correspondent | Shweta Daga Align Technology, Inc. 2820 Orchard Parkway San Jose, CA 95134 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-01 |
| Decision Date | 2022-04-07 |
Trademark Results [Invisalign System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INVISALIGN SYSTEM 75695928 not registered Dead/Abandoned |
Align Technology, Inc. 1999-05-03 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.