K202792 is an FDA 510(k) clearance for the BRIUS Clear Aligners. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Brius Technologies, Inc. (Carrollton, US). The FDA issued a Cleared decision on January 22, 2021, 122 days after receiving the submission on September 22, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion..
| 510(k) Number | K202792 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2020 |
| Decision Date | January 22, 2021 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NXC - Aligner, Sequential |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
| Definition | The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion. |