510(k) K211259 ยท EBF Material, Tooth Shade, Resin
Renamel Bulkfill
| Applicant | Cosmedent, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Jun 24, 2021 |
| Received | Apr 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211259
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.