510(k) K182778 ยท EBF Material, Tooth Shade, Resin
LC GLOSSFILL XR
| Applicant | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH, Elmshorn, DE |
| Decision | Substantially Equivalent, Apr 22, 2019 |
| Received | Oct 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182778
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.