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510(k) Data Aggregation

    K Number
    K071148
    Device Name
    ATLAS IMPLANT SYSTEM
    Manufacturer
    COWELL MEDI CO., LTD.
    Date Cleared
    2008-02-06

    (288 days)

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

    COWELL MEDI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Atlas Implant Systems are designed for use in dental implant surgery. 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. They are not intended for use of immediate loading.
    Device Description
    The Atlas Implant System includes a variety of precision-machined fixtures manufactured from titanium. These implants are surgically inserted into the upper and/or lower jawbone and serve as a replacement for a patient's tooth root providing a stable foundation for restorations.
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