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    K Number
    K161593
    Device Name
    GMI Frontier Dental Implant System
    Manufacturer
    ILERIMPLANT S.L.
    Date Cleared
    2017-01-19

    (224 days)

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

    ILERIMPLANT S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GMI Frontier Dental Implant System model is intended to be used for surgical placement in upper or lower jaw to provide a support for prosthetic devices such as artificial teeth, in order to restore the patient's chewing function. The GMI Frontier Dental Implants System is intended for delayed loading.
    Device Description
    GMI Frontier consists of dental implant, attachments (straight and angled abutments, healing abutments, ball abutments, temporary cylinders, straight and angled multi-esthetic abutments and their accessories), and clinical screws.
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