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510(k) Data Aggregation

    K Number
    K030007
    Device Name
    ITI DENTAL IMPLANT SYSTEM
    Manufacturer
    STRAUMANN USA
    Date Cleared
    2003-03-31

    (89 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K984104,K003552,K022562
    Predicate For
    K033171,K033922,K033984,K034014,K040807,K042971,K060958,K061176,K073622,K090709,K130572,K131097
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ITI dental implants are intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.

    Device Description

    ITI solid screw implants have an external spiral screw thread and an anchorage surface that is grit blasted then acid etched (SLA surface) or titanium plasmasprayed (TPS surface). The implants are composed of Grade 4 titanium, cold worked. The neck of the implant, intended to remain above the crest of the bone on implantation, is a smooth machined surface to allow for the attachment of epithelial tissue. ITI implants are available in a range of endosseous diameters (3.3 to 4.8 mm) and lengths.

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device (ITI® Dental Implant System). It claims substantial equivalence to previously marketed devices rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance studies.

    Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for this specific device's approval is not present in the provided document.

    The document states:
    "The subject ITI® dental implants are identical in intended use to currently marketed ITI® dental implants, and the indications for use covered in this 510(k) are the same as that of the predicate Branemark system dental implants. The subject ITI® implants are identical in all respects to previously cleared ITI implants. There has been no change in material, surface treatment, design, or operating principle."

    This explicitly indicates that the approval is based on substantial equivalence to existing devices that have already met regulatory requirements, not on new performance studies for this iteration of the device.

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