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    K Number
    K011879
    Device Name
    3A DENTAL IMPLANT SYSTEM
    Manufacturer
    OSSECO BIOSOURCE, LTD
    Date Cleared
    2002-08-27

    (438 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSSECO BIOSOURCE, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3A Dental Implant System is intended for single or multiple surgical implantation (with or without tissue integration) in the maxillary and or mandibular arches for the purpose of providing prosthetic support for dental restorations in partially or totally edentulous individuals. May be used for single tooth restoration.
    Device Description
    The 3A Dental Implant System is a CP titanium implant that are self-tapping or standard screw-type design. The implant body has a surface finish for either smooth (bright) or The implants are available in various insertion lengths and textured (abrasive blasted). diameters
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