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510(k) Data Aggregation

    K Number
    K974458
    Device Name
    COMPOLUTE APLICAP
    Manufacturer
    ESPE DENTAL-MEDIZIN GMBH & CO.KG.
    Date Cleared
    1998-02-02

    (69 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    **ESPE DENTAL-MEDIZIN GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Adhesive cementation of (all-porcelain-, composite-, and metal-) inlays, onlays, crowns, bridges, passive, and threaded posts and veneers
    Device Description
    The product is composed of powder and liquid portions.
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