510(k) K212767 ยท MQC Mouthguard, Prescription
SleepRight Select-Comfort Dental Guard
| Applicant | Splintek, Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Dec 22, 2021 |
| Received | Aug 31, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212767
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.