K231865 is an FDA 510(k) clearance for the Mouth Guard (ATG0603R). This device is classified as a Mouthguard, Over-the-counter.
Submitted by Reazeal Corp (Wilmington, US). The FDA issued a Cleared decision on November 6, 2023, 133 days after receiving the submission on June 26, 2023.
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 | K231865 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2023 |
| Decision Date | November 06, 2023 |
| Days to Decision | 133 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. |