K212706 is an FDA 510(k) clearance for the SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard. This device is classified as a Mouthguard, Over-the-counter.
Submitted by Splintek, Inc. (Lenexa, US). The FDA issued a Cleared decision on December 13, 2021, 109 days after receiving the submission on August 26, 2021.
This device falls under the Dental FDA review panel. To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding..
| 510(k) Number | K212706 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2021 |
| Decision Date | December 13, 2021 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | OBR - Mouthguard, Over-the-counter |
| Device Class | - |
| Definition | To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding. |