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510(k) Data Aggregation

    K Number
    K160060
    Device Name
    DMi Dental Implant System
    Manufacturer
    DMi Innovative Medical Technology Ltd.
    Date Cleared
    2016-10-03

    (265 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

    The DMi Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient chewing function.

    The DMi Dental Implant System is indicated also 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 text is a letter from the FDA regarding a 510(k) premarket notification for the DMi Dental Implant System. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot extract the requested information like:

    • A table of acceptance criteria and the reported device performance
    • Sample size used for the test set and data provenance
    • Number of experts and their qualifications for ground truth
    • Adjudication method
    • MRMC comparative effectiveness study details
    • Standalone performance details
    • Type of ground truth used
    • Sample size for the training set
    • How ground truth for the training set was established
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