510(k) K000591 ยท ELW Material, Impression
DIMENSION PENTA H, DIMENSION PENTA H QUICK
| Applicant | Espe Dental AG, Bavaria D-82228 Seefeld, DE |
| Decision | Substantially Equivalent, Mar 30, 2000 |
| Received | Feb 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000591
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2013 | 3M Company - Health Care Business 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth.
Impres Terminated |
ELW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.