K210694 is an FDA 510(k) clearance for the Silent Nite Sleep Appliance with the Glidewell Hinge. 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 June 16, 2021, 100 days after receiving the submission on March 8, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K210694 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2021 |
| Decision Date | June 16, 2021 |
| Days to Decision | 100 days |
| Submission Type | Special |
| 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 |