510(k) K252004 ยท OBR Mouthguard, Over-The-Counter
enCore Night Guard
| Applicant | Encore Guards, Santa Ana CA, US |
| Decision | Substantially Equivalent, Nov 25, 2025 |
| Received | Jun 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252004
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.