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510(k) Data Aggregation

    K Number
    K012542
    Device Name
    REVOTEK LC
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2001-10-16

    (70 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GC Revotek LC is a paste type light cured resin used to fabricate temporary crowns, bridges as well as following to temporary crowns, bridges: as used to fabricate temporary crowns, bridges as well as inlays, onlays, and veneers.

    Device Description

    GC Revotek LC is a paste type light cured resin

    AI/ML Overview

    The provided text is a letter from the FDA regarding the clearance of a medical device, Revotek LC. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot provide the requested information based on the given input.

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