LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974401
    Device Name
    4.0MM SIMPLER ONE THREADED DENTAL IMPLANT
    Manufacturer
    VANCOUVER IMPLANT RESOURCES, INC.
    Date Cleared
    1998-02-23

    (94 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

    4.0 mm Simpler One Threaded Dental Implant

    AI/ML Overview

    The provided text 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, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt.

    Therefore, I cannot provide the requested table and study details based on the given input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1