510(k) K915335 ยท EBF Material, Tooth Shade, Resin
SILICOATER SYSTEM
| Applicant | Heraeus Kulzer, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jan 21, 1992 |
| Received | Nov 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915335
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.