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510(k) Data Aggregation

    K Number
    K992067
    Device Name
    BELLEGLAZE
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Date Cleared
    1999-08-27

    (70 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K013179
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    belleGlaze is designed to be used to enhance the surface finish of the polished belleGlass restoration. It will impart a porcelain-like glaze on all surfaces, especially on posterior occlusial surfaces.

    Device Description

    The device is a resin-based, dental restorative glaze which is used to coat belleGlass restorations to give them a porcelain-like, shiny surface, especially on posterior occlusial surfaces.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document appears to be a 510(k) summary for a dental restorative glaze ("belleGlaze") and a letter from the FDA determining substantial equivalence to a predicate device.

    The document focuses on:

    • Device Name and Classification
    • Predicate Devices
    • Device Description
    • Intended Use
    • A statement of Substantial Equivalence
    • FDA's letter confirming the 510(k) clearance

    There is no mention of performance metrics, study design, sample sizes, expert involvement, or ground truth establishment. Therefore, I cannot extract the requested information.

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