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    K Number
    K051808
    Device Name
    ESTELITE FLOW QUICK
    Manufacturer
    TOKUYAMA DENTAL CORPORATION
    Date Cleared
    2005-08-08

    (34 days)

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

    ESTELITE FLOW QUICK

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

    ESTELITE FLOW QUICK is a low viscous, light cured hybrid composite dental tooth shade resin material. It is intended for use in various dental procedures, including direct anterior and posterior restorations (particularly for small/shallow/tunnel shaped cavities), as the first layer of direct restorations, blocking out cavity undercuts before fabricating indirect restorations, and repair of porcelain/composite materials.
    For use as a tooth shade resin material in dental procedures

    Device Description

    ESTELITE FLOW QUICK is a low viscous, light cured hybrid composite dental tooth shade resin material.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria for the ESTELITE FLOW QUICK device. The document is a 510(k) summary for a dental resin material, focusing on its intended use, technological characteristics, and substantial equivalence to a predicate device. It confirms FDA clearance based on substantial equivalence, but it does not detail performance studies or acceptance criteria.

    Therefore, I cannot provide the requested information.

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