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510(k) Data Aggregation

    K Number
    K012134
    Device Name
    GC E-LIGHT
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2001-08-07

    (29 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GC E-LIGHT

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

    Source of illumination for curing visible light cured dental materials such as composites, bonding agents, and cements.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to complete the acceptance criteria table and the study description. The document is an FDA 510(k) clearance letter for a device called "GC E-Light," stating that the device is substantially equivalent to legally marketed predicate devices.

    It does not include:

    • Specific acceptance criteria metrics (e.g., accuracy, sensitivity, specificity, or quantitative performance thresholds).
    • Any details about a study that proves the device meets these criteria.
    • Information about sample sizes, data provenance, ground truth establishment methods, expert qualifications, adjudication methods, or results from standalone or MRMC studies.

    The document only states the "Indications For Use" which is: "Source of illumination for curing visible light cured dental materials such as composites, bonding agents, and resin cements."

    Therefore, I cannot generate the requested table and study description based on the provided text.

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