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510(k) Data Aggregation

    K Number
    K991774
    Device Name
    ACRON MC MODIFICATION
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    1999-07-09

    (45 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

    Acron MC is a powder/liquid microwave curing denture base resin.

    Device Description

    Not Found

    AI/ML Overview

    This document (K991774) is a 510(k) premarket notification letter from the FDA regarding the Acron™ MC dental device. It does not contain any information about acceptance criteria for a device, a study proving the device meets acceptance criteria, or any of the detailed information requested in your prompt (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, training set details).

    This letter primarily states that the FDA has reviewed the submission and determined that the Acron™ MC modification is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It also outlines general regulatory information for the manufacturer.

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