510(k) K053619 ยท ELW Material, Impression
COLORBITE
| Applicant | Zhermack S.P.A., Bend OR, US |
| Decision | Substantially Equivalent, Mar 1, 2006 |
| Received | Dec 27, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053619
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.