K172223 is an FDA 510(k) clearance for the 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 November 17, 2017, 116 days after receiving the submission on July 24, 2017.
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 | K172223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2017 |
| Decision Date | November 17, 2017 |
| Days to Decision | 116 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. |