510(k) K190758 ยท EBF Material, Tooth Shade, Resin
Opus Bulk Fill APS, Opus Bulk Fill Flow APS
| Applicant | Dentscare Ltda, Joinville, BR |
| Decision | Substantially Equivalent, Sep 4, 2019 |
| Received | Mar 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190758
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.