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510(k) Data Aggregation

    K Number
    K992879
    Device Name
    ECUSIT COMPOSITE REPAIR
    Manufacturer
    Date Cleared
    1999-11-09

    (75 days)

    Product Code
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMG HAMBURG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ecusit Composite Repair is indicated for intra-oral repair of dental composite restorations.
    Device Description
    The Ecusit Composite Repair material is a single-component, methyl methacrylate-based, light-curing bonding agent specifically developed for use in intra-oral repair of poor or damaged dental composite restorations.
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