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510(k) Data Aggregation

    K Number
    K063714
    Device Name
    AXCEL FLOW
    Date Cleared
    2007-01-31

    (48 days)

    Product Code
    Regulation Number
    872.3690
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    Applicant Name (Manufacturer) :

    TRI DENTAL INNOVATORS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - Restoration of minimally invasive cavity preparations (including occuusal pits and fissures) - Conservative anterior restorations (Classes III and IV) - Base/liner under direct restorations - Repair of fillings and veneers
    Device Description
    AXCEL FLOW is a visible light cure resin-based flowable restorative dental composite material, comprised of a Bis-GMA based resin, barium glass filler and fumed silica, suitable for class III, class IV and class V restorations. It utilizes the same resin components found in AXCEL restorative composite. The cured product has high strength and a high surface luster.
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    K Number
    K051931
    Device Name
    AXCEL
    Date Cleared
    2006-02-17

    (219 days)

    Product Code
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRI DENTAL INNOVATORS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - For direct restorations, for use in all classes of cavities, including veneers and incisal edge repairs. - For indirect anterior and posterior restorations, including inlays, onlays, and veneers.
    Device Description
    AXIOM is a light-cured hybrid dental restorative composite material, comprised of a Bis-GMA based resin, barium glass filler and fumed silica, suitable for dental filings. The cured product has a high surface luster, high strength and good wear resistance.
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