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510(k) Data Aggregation

    K Number
    K974857
    Device Name
    4.0MM SIMPLER THREADED DENTAL IMPLANT
    Manufacturer
    VANCOUVER IMPLANT RESOURCES, INC.
    Date Cleared
    1998-02-27

    (60 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K011574
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use as an intra-bony, supporting component in the oral cavity to support crowns, bridges, and overdentures when replacing missing teeth.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental implant. This type of document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or effects of AI assistance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input. The letter simply states that the FDA has reviewed the submission and determined that the device is substantially equivalent to a legally marketed predicate device.

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