510(k) K964285 ยท EBF Material, Tooth Shade, Resin
TETRIC CERAM
| Applicant | Ivoclar North America, Inc., Amherst NY, US |
| Decision | Substantially Equivalent, Jan 22, 1997 |
| Received | Oct 28, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964285
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.