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510(k) Data Aggregation

    K Number
    K062343
    Device Name
    GRANDIO FLOW TRY-IN
    Manufacturer
    VOCO GMBH
    Date Cleared
    2006-11-02

    (83 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Grandio Flow Try-In assists the dentist in selecting the correct shade for cementing with Grandio Flow Try-In assists the dentist in oblocing the other watch the shades of polymerized Grandio Flow composites.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental material (Grandio Flow Try-In). It does not contain information about acceptance criteria or a study proving a device meets such criteria for an AI/ML powered device. The letter is for a physical dental product and not a software device that would typically have the kind of performance metrics you are asking about.

    Therefore, I cannot provide the requested information based on the given document.

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