510(k) K001899 ยท EBF Material, Tooth Shade, Resin
IMPROVED TRY-IN GEL
| Applicant | Sybron Dental Specialties, Inc., Orange CA, US |
| Decision | Substantially Equivalent, Aug 28, 2000 |
| Received | Jun 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001899
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2020 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restora Terminated |
EMA | None listed |
| Sep 19, 2013 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical NX3 Try-In Gel. The product is used as a tooth shade resin material. Terminated |
EBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.