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510(k) Data Aggregation

    K Number
    K973569
    Device Name
    SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY
    Manufacturer
    C.K. INTERNATIONAL TRADING
    Date Cleared
    1997-12-11

    (83 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    NON-FRECIOUS METAL ALLOY, CAST CROWN, BRIDGE, INLAYS, ONLAYS AND RESTORATION.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a "Sowell Nickel-Chrome-Molybdenum Alloy," confirming its substantial equivalence to previously marketed devices. It details the administrative aspects of the clearance and the product's intended use (dental restorations).

    There is no mention of acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies, which are typically found in a device's performance study report or marketing submission appendix, not in the clearance letter itself.

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