INVISALIGN SYSTEM
Aligner, Sequential
ALIGN TECHNOLOGY
The following data is part of a premarket notification filed by Align Technology with the FDA for Invisalign System.
Pre-market Notification Details
| Device ID | K081960 |
| 510k Number | K081960 |
| Device Name: | INVISALIGN SYSTEM |
| Classification | Aligner, Sequential |
| Applicant | ALIGN TECHNOLOGY 881 MARTIN AVE. Santa Clara, CA 95050 |
| Contact | Sangeeta Sachdeva |
| Correspondent | Sangeeta Sachdeva ALIGN TECHNOLOGY 881 MARTIN AVE. Santa Clara, CA 95050 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-09 |
| Decision Date | 2008-12-17 |
| Summary: | summary |
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.