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Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief

FDA product code MZW · Class 2 · Dental

9
Registered devices
15
Adverse events
3
Recalls
2
510(k) clearances

Devices with this code

Maxcem Elite — Kerr CorporationMaxcem Elite — Kerr CorporationMaxcem Elite — Kerr CorporationMaxcem Elite — Kerr CorporationMaxcem Elite — Kerr CorporationMaxcem Elite — Kerr CorporationMaxcem Elite — Kerr CorporationMaxcem Elite — Kerr CorporationMaxcem Elite — Kerr Corporation

Recent recalls

DateFirmReason
2013-09-23Ivoclar 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.
2013-02-22Kerr/Pentron, DBA Kerr Corporation and Pentron ClinicalKerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syrin
2011-02-03Kerr CorporationThe 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 minut

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.