Submission Details
| 510(k) Number | K252004 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
enCore Night Guard
Nov 2025
Decision
151d
Days
—
Risk
About This 510(k) Submission
K252004 is an FDA 510(k) clearance for the enCore Night Guard, 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 review panel.
Device Classification
| 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. |
Manufacturer
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