510(k) K191548 ยท EMA Cement, Dental
Nexus Universal Self-Cure
| Applicant | Kerr Corporation, Orange CA, US |
| Decision | Substantially Equivalent, Oct 11, 2019 |
| Received | Jun 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191548
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.