510(k) K990315 ยท EBF Material, Tooth Shade, Resin
MONOPAQUE
| Applicant | Ivoclar North America, Inc., Amherst NY, US |
| Decision | Substantially Equivalent, Mar 4, 1999 |
| Received | Feb 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990315
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.