K183270 is an FDA 510(k) clearance for the Silent Nite sl. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on July 17, 2019, 236 days after receiving the submission on November 23, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K183270 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2018 |
| Decision Date | July 17, 2019 |
| Days to Decision | 236 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 |