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510(k) Data Aggregation

    K Number
    K974856
    Device Name
    3.25MM 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,K083886
    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, badges, and overdentures when replacing missing teeth.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental implant. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement. The letter is a regulatory approval document and not a scientific study report.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study that proves the device meets acceptance criteria, as none of that data is present in the input.

    The document only states the "Indications for use" which are: "For use as an intra-bony, supporting component in the oral cavity to support crowns, badges, and overdentures when replacing missing teeth." This describes what the device is intended for, but not its performance metrics or acceptance criteria.

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