K252004 is an FDA 510(k) clearance for the enCore Night Guard. This device is classified as a Mouthguard, Over-the-counter.
Submitted by Encore Guards (Santa Ana, US). The FDA issued a Cleared decision on November 25, 2025, 151 days after receiving the submission on June 27, 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 | K252004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2025 |
| Decision Date | November 25, 2025 |
| Days to Decision | 151 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. |