K162306 is an FDA 510(k) clearance for the SomnoDent ALPHA. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Somnomed, Inc. (Frisco, US). The FDA issued a Cleared decision on September 20, 2016, 34 days after receiving the submission on August 17, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K162306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2016 |
| Decision Date | September 20, 2016 |
| Days to Decision | 34 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 |