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510(k) Data Aggregation

    K Number
    K160221
    Device Name
    Implance Dental Implant System, Implance Dental Abutment System
    Date Cleared
    2016-09-12

    (227 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    AGS Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Implance Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implance Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants. Implance Dental Abutment System is used with a dental implant to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as bridge or overdenture.
    Device Description
    The Implance Dental Implant System consists of titanium alloy dental implants and titanium closing screws. The Implance Dental Implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore the patient's chewing function. The surface of the implant is sand-blasted with a resorbable blast media (RBM). The provided closing screw covers the Implance Dental Implant during the healing process. The Implance Dental Implants (Table 1) are either bone level or tissue level type implants and are available in multiple designs. Bone Level Implants primarily contact bone, whereas the Tissue Level implant contacts bone and tissue along the cuff portion of the dental implant. The Implance Dental Abutment System (Table 2), consisting of titanium temporary and final abutments and screws, provides the link between the Implance Dental Implant and the prosthesis that forms the superstructure and allows chewing. Final, permanent abutments are available in multiple designs and range in diameter from 2.9 mm to 6.5 mm; cuff heights of 0.5 mm to 5 mm and lengths of 7 mm to 16.4 mm.
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