510(k) K222435 · EBF Material, Tooth Shade, Resin
Renamel® Microhybrid ;Renamel® Flowable Microhybrid
| Applicant | Cosmedent, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Oct 11, 2022 |
| Received | Aug 12, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222435
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.