K210203 is an FDA 510(k) clearance for the mmRNA appliance. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) (Highland Ranch, US). The FDA issued a Cleared decision on August 19, 2021, 205 days after receiving the submission on January 26, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K210203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2021 |
| Decision Date | August 19, 2021 |
| Days to Decision | 205 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LRK - Device, Anti-snoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |