510(k) K980054 ยท EBF Material, Tooth Shade, Resin
PALFIQUE ESTELITE
| Applicant | Tokuyama America, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Apr 27, 1998 |
| Received | Jan 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980054
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.