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    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    T.A.G. Dental Implant System

    K Number: K143326 · Decision May 14, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    11
    Review Days
    175

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    Basic Information

    Device Name
    T.A.G. Dental Implant System
    K Number
    K143326
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    T.A.G. Medical Products Corporation, Ltd.
    Date Received
    November 20, 2014
    Decision Date
    May 14, 2015
    Product Code
    DZE
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DZE Implant, Endosseous, Root-Form

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