510(k) K112501 ยท EBF Material, Tooth Shade, Resin
VENUS PEARL PLT REFILL A1
| Applicant | Heraeus Kulzer, LLC, South Bend IN, US |
| Decision | Substantially Equivalent, Dec 14, 2011 |
| Received | Aug 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112501
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.