510(k) K061664 ยท EBF Material, Tooth Shade, Resin
FORMCORE DC, MODEL 28-700100
| Applicant | J. Morita USA, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 8, 2006 |
| Received | Jun 14, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061664
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.