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510(k) Data Aggregation

    K Number
    K984365
    Device Name
    GC UNIFAST TRAD
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    1999-02-25

    (80 days)

    Product Code
    EBI,FEB
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GC UNIFAST TRAD

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

    GC Unifast Trad is an acrylic resin used in a variety of dental applications such as repair of full or partial acrylic dentures. Construction of temporary crowns. Impression trays for individual teeth. Check bit registration. Construction and repair of orthodontic plates and splints.

    Device Description

    GC Unifast Trad is an acrylic resin.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental device called "GC Unifast Trad". It does not contain information about acceptance criteria or a study proving device performance as would be found in a clinical study report or a more detailed submission summary.

    Therefore, I cannot extract the requested information using only the provided text. The document primarily focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance study results.

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