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510(k) Data Aggregation

    K Number
    K012160
    Device Name
    COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2001-09-27

    (78 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

    CompCore™ AF is an automix, fluoride releasing, resin composite material designed for the direct fabrication of core build-ups.

    Device Description

    CompCore™ AF is an automix, fluoride releasing, resin composite material designed for the direct fabrication of core build-ups.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment relevant to the device "CompCore™ AF."

    The document is a 510(k) premarket notification letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general information but does not include any study details or performance data as requested in your prompt.

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