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510(k) Data Aggregation

    K Number
    K132937
    Device Name
    HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)
    Manufacturer
    HARVEST DENTAL PRODUCTS, LLC
    Date Cleared
    2014-05-21

    (245 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K153753
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Harvest Dental Polymer Blocks (ZCAD) are PMMA blanks for manufacturing temporary crowns and bridges by a CAD/CAM system.

    Device Description

    Harvest Dental Polymer Blocks (ZCAD) are PMMA blanks.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product. It does not contain information about acceptance criteria for a device's performance through a study. Instead, it is a regulatory document confirming substantial equivalence based on prior predicate devices.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document does not discuss performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

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