K212767 is an FDA 510(k) clearance for the SleepRight Select-Comfort Dental Guard. This device is classified as a Mouthguard, Prescription.
Submitted by Splintek, Inc. (Lenexa, US). The FDA issued a Cleared decision on December 22, 2021, 113 days after receiving the submission on August 31, 2021.
This device falls under the Dental FDA review panel.
| 510(k) Number | K212767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2021 |
| Decision Date | December 22, 2021 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |