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510(k) Data Aggregation

    K Number
    K070319
    Device Name
    GC FUJI IX GP EXTRA
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2007-02-26

    (24 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Class I and II restorations in deciduous teeth Non-load bearing Class I and II restorations in permanent teeth Immediate restorative and base material for heavy stress situation in Class I and II cavities using sandwich laminate technique Class V and root surface restorations Core build up

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to GC America, Incorporated for a dental cement called "GC Fuji IX GP EXTRA". This document is a regulatory approval and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria as typically found in a clinical trial report or scientific publication for AI/ML devices.

    Therefore, I cannot extract the requested information regarding acceptance criteria and study details. This document is a regulatory approval and does not describe technical performance metrics or how they were tested.

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