BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 3447126 · Received October 15, 2013

    Report

    Report Number
    9610902-2013-00104
    Event Type
    Injury
    Date Received
    October 15, 2013
    Manufacturer
    HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. REVIEWED THE DIRECTIONS FOR USE FOR CALM-IT BY DENTSPLY CAULK AND OTHER (B)(4) CONTAINING DESENSITIZER. NONE HAVE A CONTRAINDICATION FOR USE WITH AN RMGI CEMENT. REVIEWED THE DIRECTIONS FOR USE FOR RELYX LUTING CEMENT, ALL DENTSPLY CAULK CEMENTS AND OTHER RMGI CEMENTS AND NONE OF THEM CARRY A CONTRAINDICATION FOR USE WITH A (B)(4) CONTAINING DESENSITIZER. FOUND REPORT IN JADA BY EJ SWIFT JR, AH LLOYD AND DA FELTON: THE EFFECT OF RESIN DESENSITIZING AGENTS ON CROWN RETENTION. RESULTS: " THIS LAB STUDY CONCLUDED THAT TWO POPULAR RESINS, GLUMA DESENSITIZER (B)(4), HAD LITTLE OR NO EFFECT ON THE RETENTION OF CROWNS LUTED WITH ZINC PHOSPHATE, GLASS IONOMER OR RESIN-MODIFIED GLASS IONOMER CEMENTS." FOUND J ADV PROSTHODONT, (B)(4) 28. COMPARISON OF EFFECT OF DESENSITIZING AGENTS ON THE RETENTION OF CROWNS CEMENTED WITH LUTING AGENTS: AN IN VITRO STUDY. JALANDAR SS, PANDHARINATH DS, ARUN K, SMITA V. RESULTS: RESIN MODIFIED GLASS IONOMER CEMENT EXHIBITED THE HIGHEST RETENTION STRENGTH AND ALL DENTIN TREATMENTS RESULTED IN SIGNIFICANTLY DIFFERENT RETENTIVE VALUES 9IN KG.): GLUMA (49.02- 3.32). THE USE OF GLUMA DESENSITIZER HAS NO EFFECT ON CROWN RETENTION.

    Description of Event or Problem · 1

    REFERENCE IMPORTER REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527186 GLUMA DESENSITIZER KLE TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1