K233434 is an FDA 510(k) clearance for the Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG). 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 November 14, 2023, 32 days after receiving the submission on October 13, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K233434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 2023 |
| Decision Date | November 14, 2023 |
| Days to Decision | 32 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 |