Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K051576
    Device Name
    AVANA DENTAL IMPLANT SYSTEM
    Manufacturer
    OSSTEM CO., LTD.
    Date Cleared
    2005-09-01

    (79 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why 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.
    Ask a Question

    Page 1 of 1