510(k) K073209 ยท MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
MAXCEM 2
| Applicant | Kerr Corporation, Orange CA, US |
| Decision | Substantially Equivalent, Jan 29, 2008 |
| Received | Nov 14, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073209
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2013 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0.
Used for cementation of all indirect restorations. Terminated |
MZW | None listed |
| Jan 27, 2012 | Kerr Corporation Brand name: Maxcem Elite,
Product: a dental cement,
Part Number: 34418.
The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based Terminated |
MZW | None listed |
| Jan 11, 2012 | Henry Schein, Inc. Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part # 33872, CLEAR --- Refill Kit Contents: 2 Syringes (5 g ea), 10 Automix tips (regular) 4:1, 10 Automix tips ( Terminated |
EMA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.