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510(k) Data Aggregation

    K Number
    K172345
    Device Name
    IU Implant System
    Manufacturer
    Warantec Co.,Ltd.
    Date Cleared
    2018-06-18

    (320 days)

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

    Warantec Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IU Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
    Device Description
    The IU Implant System is an integrated system of endosseous dental implants with corresponding various abutments (cover screw, two piece abutment, solid abutment, abutment screw, ball abutment, retained abutment, temporary abutment, and multi abutment). The IU Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. There are two types of Fixtures, triangular screw threads design and square screw threads design. The IU Implant System includes the each fixtures is available in various diameters (lengths) 3.6 mm (8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 4.1 mm, 4.6 mm, 5.1 mm, 5.6 mm, 6.1 mm (7.5 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) of triangular screw threads design and 4.3 mm, 4.8 mm, 5.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 6.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm) of square screw threads design according to the anatomical situation. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. Abutment is device made of titanium alloy and it is intended for use to make permanent prostheses and/or temporary prosthesis. The abutments are provided non-sterile and should be sterilized before use.
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