K132506 is an FDA 510(k) clearance for the SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Michael D Williams Dds PA (Davie, US). The FDA issued a Cleared decision on May 29, 2014, 290 days after receiving the submission on August 12, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K132506 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2013 |
| Decision Date | May 29, 2014 |
| Days to Decision | 290 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 |