LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K100785
    Device Name
    BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
    Manufacturer
    BONART CO. LTD.
    Date Cleared
    2010-12-03

    (259 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ART-IM1 Implantor is an implant machine system. It is primarily used by dental professionals in doing oral implant surgery or implantology such as drilling, reaming, cutting, etc. This system is also used for fixing previous broken or failed implant procedure.

    Device Description

    BonartART-IM1 Implantor System & Accessories

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a dental implant machine system, the BonartART-IM1 Implantor System & Accessories. It establishes substantial equivalence to a predicate device based on its indications for use.

    However, the document is a regulatory approval letter and an indication for use statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the detailed study parameters requested in your prompt.

    Therefore, I cannot populate the requested information from the provided text. The document is concerned with regulatory approval based on substantial equivalence, not a detailed performance study as would be seen for AI/ML devices or novel diagnostic tools.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1