510(k) K212706 ยท OBR Mouthguard, Over-The-Counter
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
| Applicant | Splintek, Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Dec 13, 2021 |
| Received | Aug 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212706
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.