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510(k) Data Aggregation

    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
    Not Found
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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
    Ask a Question
    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
    Ask a Question
    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
    Ask a Question

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