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 | K143630 |
| 510k Number | K143630 |
| Device Name: | Invisalign System |
| Classification | Aligner, Sequential |
| Applicant | ALIGN TECHNOLOGY, INC. 2560 Orchard Parkway San Jose, CA 95131 |
| Contact | Margaret Anderson |
| Correspondent | Margaret Anderson ALIGN TECHNOLOGY, INC. 2560 Orchard Parkway San Jose, CA 95131 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-22 |
| Decision Date | 2015-11-18 |
| 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 |
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