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510(k) Data Aggregation

    K Number
    K012360
    Device Name
    LC TEMPORARY FILLING
    Manufacturer
    PARKELL, INC.
    Date Cleared
    2001-09-06

    (43 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A light-cured resin intended for use as a temporary restorative material in a tooth prepared to receive an inlay or onlay until such time as the laboratory fabricated final restoration can be inserted into that tooth.

    Device Description

    A light-cured resin intended for use as a temporary restorative material in a tooth prepared to receive an inlay or onlay until such time as the laboratory fabricated final restoration can be inserted into that tooth.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) summary for a dental temporary filling material, which focuses on regulatory approval and substantial equivalence to existing devices. It does not include details about acceptance criteria, performance studies, or clinical trial methodologies as would be expected for a diagnostic or AI-powered device.

    Therefore, I cannot provide:

    1. A table of acceptance criteria and reported device performance
    2. Sample size used for the test set and data provenance
    3. Number and qualifications of experts for ground truth
    4. Adjudication method
    5. MRMC comparative effectiveness study results or effect size
    6. Standalone performance details
    7. Type of ground truth used
    8. Sample size for the training set
    9. How ground truth for the training set was established
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