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510(k) Data Aggregation

    K Number
    K161743
    Device Name
    Etgar Dental Implant System
    Manufacturer
    ETGAR MEDICAL INSTRUMENTS, LTD
    Date Cleared
    2017-04-14

    (294 days)

    Product Code
    DZE,NHA
    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

    Intended to replace one or more missing teeth in the upper or lower jaw in partially or fully edentulous patients in order to restore chewing function. Intended to support single or multiple tooth prostheses can be screwed or cement retained to the abutment. Intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided documentation is a 510(k) clearance letter for a medical device (Etgar Dental Implant System) from the FDA. This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance. It does not typically contain information about clinical study designs, acceptance criteria, specific device performance metrics, or ground truth establishment relevant to AI/ML software performance.

    Therefore, I cannot extract the information requested the prompt, which are common in device approvals that leverage AI/ML algorithms.

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