510(k) K222604 ยท MQC Mouthguard, Prescription
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
| Applicant | Dentona AG, Dortmund, DE |
| Decision | Substantially Equivalent, Apr 21, 2023 |
| Received | Aug 29, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222604
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.