K222424 is an FDA 510(k) clearance for the Protect-It Custom Fit Dental Guard. This device is classified as a Mouthguard, Over-the-counter.
Submitted by Doc Brands, Inc. (Wayne, US). The FDA issued a Cleared decision on October 7, 2022, 57 days after receiving the submission on August 11, 2022.
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 | K222424 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2022 |
| Decision Date | October 07, 2022 |
| Days to Decision | 57 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. |