510(k) K082671 ยท EBF Material, Tooth Shade, Resin
HERCULITE ULTRA
| Applicant | Sybron Dental Specialties, Orange CA, US |
| Decision | Substantially Equivalent, Dec 11, 2008 |
| Received | Sep 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082671
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2010 | Sybron Dental Specialties Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA. Terminated |
EBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.