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510(k) Data Aggregation

    K Number
    K083398
    Device Name
    CERCOM CEMENT
    Date Cleared
    2009-01-26

    (70 days)

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

    DENALI R&D CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CERCOM Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations
    Device Description
    CERCOM Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations
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    K Number
    K083473
    Device Name
    CLEAR BRAVO
    Date Cleared
    2009-01-22

    (59 days)

    Product Code
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENALI R&D CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Clear Bravo is a clear, light-cured pit and fissure sealant and sealer for application to the surfaces of teeth, sealing of composite margins and temporary restorations Clear Bravo is available in either fluoride and non-fluoride releasing formulas
    Device Description
    Clear Bravo is a clear, light-cured pit and fissure sealant and sealer for application to the surfaces of teeth, sealing of composite margins and temporary restorations Clear Bravo is crystal clear which allows observation of conditions which may occur beneath the sealant This would include possible leakage, staming and also allows the use of canes detecting devices Clear Bravo is available in either fluoride and non-fluoride releasing formulas
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