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510(k) Data Aggregation

    K Number
    K022009
    Device Name
    3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS
    Manufacturer
    IMPLANT INNOVATIONS, INC.
    Date Cleared
    2002-12-30

    (194 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K874590,K014265,K935544,K980549,K983347,K013570
    Predicate For
    K030614,K031475,K031632,K040807,K051461,K052254,K062636,K063286,K063341,K063364,K073622,K082800
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    3i Dental Implant Systems are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

    Device Description

    Implant Innovation's dental implant systems are available in a wide range of diameters and lengths. 3i implants include screw-form (i.e., threaded) or cylinder; are manufactured from titanium; and are coated or non-coated. The OSSEOTITE® brand implants have a special dual acid-etched treatment process to increase surface roughness.

    AI/ML Overview

    The provided text is a U.S. FDA 510(k) summary for a dental implant system. It outlines the device, its indications for use, and a comparison to predicate devices, ultimately leading to a substantial equivalence determination.

    However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

    The document is a regulatory submission for premarket notification, not a clinical study report. It focuses on demonstrating substantial equivalence to existing devices, which is a different type of evaluation than proving a device meets specific performance criteria through a dedicated study.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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