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510(k) Data Aggregation

    K Number
    K110058
    Device Name
    BPA-FREE PIT AND FISSURE SEALANT
    Manufacturer
    NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
    Date Cleared
    2011-03-31

    (80 days)

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

    NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "BPA-Free Pit and Fissure Sealant" is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces.
    Device Description
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    K Number
    K101540
    Device Name
    GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
    Manufacturer
    NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
    Date Cleared
    2010-10-29

    (148 days)

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

    NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Granitec® Dual-Cure Core Build-Up is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure and core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent. N'Durance Dimer Core is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure an d core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.
    Device Description
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