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 |