K183315 is an FDA 510(k) clearance for the CustMBite Dental Guard. This device is classified as a Mouthguard, Over-the-counter.
Submitted by Dental Choice Holdings, LLC (Louisville, US). The FDA issued a Cleared decision on August 23, 2019, 266 days after receiving the submission on November 30, 2018.
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 | K183315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2018 |
| Decision Date | August 23, 2019 |
| Days to Decision | 266 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. |