510(k) K193537 ยท EBF Material, Tooth Shade, Resin
Omnichroma Flow
| Applicant | Tokuyama Dental Corporation, Tokyo, JP |
| Decision | Substantially Equivalent, Aug 19, 2020 |
| Received | Dec 20, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193537
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.