510(k) K000173 ยท EMA Cement, Dental
CEMENT IT! UNIVERSAL C&B
| Applicant | Jeneric/Pentron, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Feb 29, 2000 |
| Received | Jan 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000173
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Kerr/pentron Dba Kerr Corporation And Pentron Clinical Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It).
The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Ce Terminated |
EMA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.