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510(k) Data Aggregation

    K Number
    K020342
    Device Name
    UNIFIL FLOW
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2002-03-28

    (55 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UNIFIL FLOW

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

    GC UniFil Flow is intended to be used for small class I & II :restora ions. · And Class III, IV and V restorations. Other uses include: Base and Liner, sealing for hypersensitivity, Pit and fissure sealar fixation of mobile teeth and repair of resin composite.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental material (GC UniFil Flow), indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and indications for use but does not present performance data or study details.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text.

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