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510(k) Data Aggregation
K Number
K172345Device Name
IU Implant System
Manufacturer
Warantec Co.,Ltd.
Date Cleared
2018-06-18
(320 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why 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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