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510(k) Data Aggregation

    K Number
    K073106
    Device Name
    UNIFAST III
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2008-04-11

    (161 days)

    Product Code
    EBG,EBI
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UNIFAST III

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

    Unifast III is a self-curing acrylic resin used for a variety of dental applications, including construction of temporary inlays, crowns and bridges and repair of fractured dentures in either pressure or paint on techriiques.

    Device Description

    Unifast III is a self-curing acrylic resin.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a dental resin product called "Unifast III," confirming its substantial equivalence to a predicate device. It specifies general controls, regulations, and indications for use but does not detail performance studies, acceptance criteria, sample sizes, or ground truth establishment.

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