K190687 is an FDA 510(k) clearance for the Twilite Appliance. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Stephen J Harkins, Dds, PC (Tucson, US). The FDA issued a Cleared decision on July 2, 2019, 106 days after receiving the submission on March 18, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K190687 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2019 |
| Decision Date | July 02, 2019 |
| Days to Decision | 106 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 |