K251778 is an FDA 510(k) clearance for the Remi Custom Night Guard. This device is classified as a Mouthguard, Over-the-counter.
Submitted by Remi (San Francisco, US). The FDA issued a Cleared decision on October 17, 2025, 129 days after receiving the submission on June 10, 2025.
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 | K251778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2025 |
| Decision Date | October 17, 2025 |
| Days to Decision | 129 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. |