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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) :

    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
    Not Found
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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) :

    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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    K Number
    K042212
    Device Name
    IMPLANTMASTER
    Manufacturer
    I-DENT
    Date Cleared
    2004-10-21

    (66 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    I-DENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ImplantMaster system is indicated for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for use by qualified dental professionals to aid them in the placement of dental implants and surgical treatment. ImplantMaster processes the dental professional's input information and the result is used as an input data for CAD or Rapid Prototyping System.
    Device Description
    The ImplantMaster system is a software interface used for the transfer of imaging information from a medical scanner such as a CT scanner, processing it and planning dental implant placement and surgical treatment. The ImplantMaster processes output result is used as an input data for CAD or Rapid Prototyping System.
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    K Number
    K030807
    Device Name
    CARIES INDICATOR
    Manufacturer
    CONFI-DENTAL PRODUCTS CO.
    Date Cleared
    2003-06-09

    (88 days)

    Product Code
    LFC
    Regulation Number
    872.1740
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONFI-DENTAL PRODUCTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Caries Indicator is indicated for the following applications: Designed to be used to help identify caries in dentin.
    Device Description
    Not Found
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    K Number
    K030743
    Device Name
    ETCHANT 40%
    Manufacturer
    CONFI-DENTAL PRODUCTS CO.
    Date Cleared
    2003-05-09

    (60 days)

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

    CONFI-DENTAL PRODUCTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Etchant 40% is indicated for initiation of the bonding sequence for bonding restorative materials to enamel and/or dentin.
    Device Description
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    K Number
    K955328
    Device Name
    CONFI-BOND
    Manufacturer
    CONFI-DENTAL PRODUCTS CO.
    Date Cleared
    1996-03-28

    (129 days)

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

    CONFI-DENTAL PRODUCTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955329
    Device Name
    RESILIENCE M5 PROTECTION PLUS
    Manufacturer
    CONFI-DENTAL PRODUCTS CO.
    Date Cleared
    1996-03-28

    (129 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONFI-DENTAL PRODUCTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954988
    Device Name
    CRYSTALLESSENCE
    Manufacturer
    CONFI-DENTAL PRODUCTS CO.
    Date Cleared
    1996-03-08

    (129 days)

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

    CONFI-DENTAL PRODUCTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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