510(k) K250456 ยท OBR Mouthguard, Over-The-Counter
Dentemp Pro-Comfort Dental Guard
| Applicant | Doc Brands, Inc., Wayne PA, US |
| Decision | Substantially Equivalent, May 19, 2025 |
| Received | Feb 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250456
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.