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510(k) Data Aggregation

    K Number
    K130829
    Device Name
    IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS
    Manufacturer
    IQ IMPLANTS LTD.
    Date Cleared
    2013-11-14

    (233 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    IQ IMPLANTS LTD.

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

    IQ 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's chewing function. IQ 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 does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement. The document is an FDA 510(k) clearance letter for the IQ Implant System, confirming its substantial equivalence to a predicate device and outlining regulatory responsibilities. It does not include a scientific study or performance data.

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