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510(k) Data Aggregation

    K Number
    K982537
    Device Name
    TOKUYAMA SOFRELINER
    Manufacturer
    TOKUYAMA AMERICA, INC.
    Date Cleared
    1998-08-24

    (34 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K990666,K021382,K973950,K791696
    Predicate For
    K030663
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use as a denture reliner

    Device Description

    The product is a denture relining resin material for use in relining the tissue contact surface of dentures. It is not intended for over-the-counter (OTC) use. It contains materials that are common in dental use and pose no health hazard when used according to directions.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or any study that proves a device meets such criteria. The document is a 510(k) summary for a denture relining resin material (Tokuyama SOFRELINING) and a letter from the FDA determining substantial equivalence to predicate devices. It discusses the device's classification, indications for use, and regulatory compliance but does not detail performance acceptance criteria or specific studies beyond referencing the 510(k) notification.

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