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510(k) Data Aggregation

    K Number
    K013510
    Device Name
    POINT 4 MODIFIED
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2002-01-18

    (88 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

    Point 4 Modified is a dental composite restorative material intended to be used in all classes of cavities

    Device Description

    The device is a micro-hybrid light cured resin-based dental restorative which contains approximately 79% by weight (59% by volume) inorganic filler but with a particle size nearly half that of Kerr's Herculite XRV and Prodigy. This breakthrough in filler technology provides a higher, longer-lasting polish similar to a microfill, without any negative effects to the physical properties.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance details, or any study conducted to prove the device meets acceptance criteria. The document is a 510(k) summary for a dental composite restorative material, Point 4 Modified, and largely focuses on its intended use, device description, and substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.

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