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Maxcem Elite
Kerr Corporation · Model 36038 · UDI-DI 00841396107238
MZW
Prescription
2
510(k) clearances
15
Adverse events
3
Recalls
11
Facilities
Description
Universal Resin Cement; Sample (NA) - Not For Resale
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-09-23 | Ivoclar Vivadent, Inc. | Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements. |
| 2013-02-22 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical | Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product coul |
| 2011-02-03 | Kerr Corporation | The recall was initiated because Kerr Corporation has confirmed that the use of the affected lot of Maxcem Elite may not provide users with a minimum of 2 minutes of worktime there |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.