K181416 is an FDA 510(k) clearance for the Sapphire Dorsal Comfort Fit. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Crane Dental Laboratory, Inc. (Rochester, US). The FDA issued a Cleared decision on September 17, 2019, 474 days after receiving the submission on May 31, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K181416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2018 |
| Decision Date | September 17, 2019 |
| Days to Decision | 474 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 |