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510(k) Data Aggregation

    K Number
    K051358
    Device Name
    NATURE-CRYL HI PLUS
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2005-07-07

    (44 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use in the fabrication of full and partial dentures using conventional heat cured dough pack and or injection processing technique.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental resin, Nature-Cryl™ Hi Plus, used for fabricating dentures. It is not a study that proves a device meets acceptance criteria.

    Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as these elements are not present in this type of regulatory correspondence.

    The letter simply states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market. It does not contain the detailed performance study information you are asking for.

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