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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
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CARIES INDICATOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Caries Indicator is indicated for the following applications: Designed to be used to help identify caries in dentin.

    Device Description

    Not Found

    AI/ML Overview

    This FDA letter confirms substantial equivalence for a Caries Indicator device (K030807), but it does not contain any information about acceptance criteria or a study proving the device meets said criteria.

    The letter is a regulatory document affirming that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not include performance data or details of clinical studies.

    Therefore, I cannot provide the requested information based on the provided text.

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    K Number
    K963927
    Device Name
    TEAM CARIES INDICATOR
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    1996-11-15

    (66 days)

    Product Code
    LFC
    Regulation Number
    872.1740
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TEAM CARIES INDICATOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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