K221369 is an FDA 510(k) clearance for the FBCC Night Guard. This device is classified as a Mouthguard, Over-the-counter.
Submitted by Fbcc, Inc. (Los Angeles, US). The FDA issued a Cleared decision on November 18, 2022, 190 days after receiving the submission on May 12, 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 | K221369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2022 |
| Decision Date | November 18, 2022 |
| Days to Decision | 190 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. |