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510(k) Data Aggregation
K Number
K081748Device Name
ONEPLANT DENTAL IMPLANT SYSTEM
Manufacturer
WARANTEC CO., LTD.
Date Cleared
2009-03-27
(281 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
WARANTEC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ONEPLANT is designed for use in dental implant Surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework.
Device Description
Dental implant systems are devices made of a material such as titanium 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 patients chewing function. Dental implant system consists of Fixture, Abutment and Implant surgical instruments.
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