510(k) K253641 ยท OBR Mouthguard, Over-The-Counter
Owl Night Guard
| Applicant | Owl Dental Lab, Inc., San Leandro CA, US |
| Decision | Substantially Equivalent, Feb 26, 2026 |
| Received | Nov 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253641
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.