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510(k) Data Aggregation

    K Number
    K974403
    Device Name
    3.25MM SIMPLER ONE PUSHIN 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
    N/A
    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

    3.2.5 mm Simpler One Pushin Dental Implant

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental implant. It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information based on the provided text. The letter only confirms the regulatory clearance of the 3.25mm Simpler One Pushin Dental Implant.

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