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510(k) Data Aggregation

    K Number
    K974402
    Device Name
    3.25 MM SIMPLER ONE THREADED DENTAL IMPLANT
    Manufacturer
    VANCOUVER IMPLANT RESOURCES, INC.
    Date Cleared
    1998-02-19

    (90 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

    3.25mm Simpler One Threaded Dental Implant

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a 510(k) clearance letter from the FDA for a dental implant, which indicates that the device is substantially equivalent to a previously marketed device. It does not include details on specific performance metrics, study design, or results.

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