The following data is part of a premarket notification filed by Align Technology with the FDA for Align System.
| Device ID | K981095 |
| 510k Number | K981095 |
| Device Name: | ALIGN SYSTEM |
| Classification | Aligner, Sequential |
| Applicant | ALIGN TECHNOLOGY 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson ALIGN TECHNOLOGY 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-26 |
| Decision Date | 1998-09-08 |
| Summary: | summary |