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510(k) Data Aggregation

    K Number
    K081579
    Device Name
    INVENTUS IMPLANT SYSTEM
    Manufacturer
    Date Cleared
    2008-09-17

    (104 days)

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

    INVENTUS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Inventus Implant System is a series of titanium endosseous dental implants and accessories for surgical implantation in the upper and/or lower jaw. It is intended to artificially provide a root structure to support prosthetic devices, such as artificial teeth, in order to restore the chewing function of the patient.
    Device Description
    The Inventus Implant System consists of a series of root-form endosseous dental fixtures (implant) and accessories designed to support single or multiple restorations. The implants and abutments are manufactured from titanium, conforming to ASTM F67, and the screws are manufactured from titanium alloy, conforming to ASTM F136. The implants are available in @3.3mm, @3.75mm, Φ4.0mm, Φ5.5mm and Φ6.0mm diameters and vary in length from 9.0mm to 18.3mm. For optimal osseointegration, the implant surfaces are treated with resorbable blast media (RBM) incorporating hydroxylapatite (HA) powder.
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