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510(k) Data Aggregation

    K Number
    K071410
    Device Name
    ARGEN PEARL BRAND ZIRCONIA
    Manufacturer
    THE ARGEN CORPORATION
    Date Cleared
    2007-08-15

    (86 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ARGEN PEARL BRAND ZIRCONIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Argen PEARL brand zirconia is intended for CAD/CAM fabrication of all-ceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

    Device Description

    Not Found

    AI/ML Overview

    Based on the provided text, the document is a 510(k) clearance letter from the FDA for a dental material (Argen PEARL Brand Zirconia), not a study report for an AI/device for diagnostics or prediction. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or diagnostic devices, is not present in this document.

    The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than a detailed performance study against specific acceptance criteria.

    Therefore, it is not possible to extract the requested information from this document.

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