510(k) K180933 ยท OBR Mouthguard, Over-The-Counter
DenTek Ultimate Dental Guard
| Applicant | Medtech Products, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Sep 17, 2018 |
| Received | Apr 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180933
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.