The following data is part of a premarket notification filed by Brius Technologies, Inc with the FDA for Brius Clear Aligners.
| Device ID | K202792 |
| 510k Number | K202792 |
| Device Name: | BRIUS Clear Aligners |
| Classification | Aligner, Sequential |
| Applicant | Brius Technologies, Inc 2611 Westgrove Dr Ste 109 Carrollton, TX 75006 |
| Contact | Kate Garrett |
| Correspondent | Jennifer Day Medavice, Inc. 11218 Zest Ct. NE Blaine, MN 55449 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-22 |
| Decision Date | 2021-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002991016 | K202792 | 000 |