510(k) K251778 ยท OBR Mouthguard, Over-The-Counter
Remi Custom Night Guard
| Applicant | Remi, San Francisco CA, US |
| Decision | Substantially Equivalent, Oct 17, 2025 |
| Received | Jun 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251778
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.