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    K Number
    K063714
    Device Name
    AXCEL FLOW
    Manufacturer
    TRI DENTAL INNOVATORS
    Date Cleared
    2007-01-31

    (48 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K051931,K013647
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Restoration of minimally invasive cavity preparations (including occuusal pits and fissures)
    • Conservative anterior restorations (Classes III and IV)
    • Base/liner under direct restorations
    • Repair of fillings and veneers
    Device Description

    AXCEL FLOW is a visible light cure resin-based flowable restorative dental composite material, comprised of a Bis-GMA based resin, barium glass filler and fumed silica, suitable for class III, class IV and class V restorations. It utilizes the same resin components found in AXCEL restorative composite. The cured product has high strength and a high surface luster.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a dental restorative material called AXCEL FLOW. It does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, or comparative effectiveness studies of an AI-powered device.

    This document is a regulatory submission for a physical dental material, not a software or AI-driven diagnostic device. Therefore, it does not address the specific points requested in your prompt related to AI/software performance evaluation.

    To answer your request, I need a different type of document, specifically one that describes a study evaluating an AI or software device.

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