K230947 is an FDA 510(k) clearance for the C.A.R.E. Appliance (DNA, mRNA, mmRNA). This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Vivos Therapeutics, Inc. (Murray, US). The FDA issued a Cleared decision on November 28, 2023, 238 days after receiving the submission on April 4, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K230947 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2023 |
| Decision Date | November 28, 2023 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| 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 |