510(k) K060698 ยท EMA Cement, Dental
CEMENT-IT ALL PURPOSE, MODEL N97
| Applicant | Pentron Clinical Technologies, Wallingford CT, US |
| Decision | Substantially Equivalent, May 10, 2006 |
| Received | Mar 16, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060698
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2012 | Kerr Corporation Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts. Terminated |
EMA | None listed |
| Nov 14, 2011 | Kerr/pentron Dba Kerr Corporation And Pentron Clinical Breeze Self-Adhesive Resin Cement, Part Number: N97A,
Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts Terminated |
EMA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.