510(k) K111310 ยท OBR Mouthguard, Over-The-Counter
BRUX MOUTHGUARDS
| Applicant | Dental Arte, Inc., Braderdon FL, US |
| Decision | Substantially Equivalent, Dec 8, 2011 |
| Received | May 10, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111310
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.