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510(k) Data Aggregation
K Number
K132956Device Name
U FIT DENTAL IMPLANT SYSTEM
Manufacturer
T STRONG, INC
Date Cleared
2014-06-05
(258 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
T STRONG, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The U fit Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The U fit Dental Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
Device Description
The U fit Implant System is a dental implant system made of Titanium-6A1-4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for lading affer a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with RBM (Resorbable Blasted Media). The Fixture diameters are 3.8, 3.9, 4.0, 4.1, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm and lengths are 7. 8.5, 10. 11.5, 13, 14.5 mm in this system. The contained various abutments and accessories in the system are cover screw, abutment screw, healing abutment, solid abutment, transfer abutment, milling abutment, Temporary Abutment, protect cap, solid impression coping, solid lab analog, impression coping/pick-up, impression coping/transfer, and fixture lab analog. The material of abutments and accessories are Ti-6A1-4V ELI(ASTM F-136), POM-C and stainless steel. The abutment diameters are 4.0, 4.1, 4.4, 4.5, 4.8, 5.0, 5.5, 5.8, 6.0, 6.3, 6.5, 6.8, 7.0, 7.3, 7.8 and Heights are 4.0, 5.5, 7.0, 9.0. The implants are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use.
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