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510(k) Data Aggregation
K Number
K051576Device Name
AVANA DENTAL IMPLANT SYSTEM
Manufacturer
OSSTEM CO., LTD.
Date Cleared
2005-09-01
(79 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
OSSTEM CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AVANA Dental Implant Systems are designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium fixture when surgically implanted under controlled conditions, as per well known clinical studies. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
Device Description
The Avana SS-II Implant is a threaded, root form endosseous implant comprised of an internal octa, one-stage 8° morse tapered device manufactured from commercially pure titanium. The implant's external threaded surfaces are roughened to facilitate tissue and bone integration. The implant's self-tapping feature may be used with or without pre-tapping the bone. System components for restorative purposes include: screw-on and cemented abutments, healing abutments, and angled abutments. Surgical accessories include drills, depth gages, drivers, torque wrenches, taps, reamers and fixture mount removal tool.
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