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510(k) Data Aggregation

    K Number
    K993013
    Device Name
    SURE BOND
    Manufacturer
    MIRADENT DISTRIBUTING CO., LLC.
    Date Cleared
    1999-11-29

    (83 days)

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

    MIRADENT DISTRIBUTING CO., LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device/method is a means of conditioning enamel and dentin to Obtain adhesive bonding of polymeric materials. It is used by dental professionals in restorative procedures.
    Device Description
    Not Found
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