BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EZ PLUS IMPLANT SYSTEM

    K Number: K070562 · Decision May 18, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    390
    Registration Numbers
    390
    Same Product Code
    672
    Applicant Total
    9
    Review Days
    80

    Basic Information

    Device Name
    EZ PLUS IMPLANT SYSTEM
    K Number
    K070562
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEGAGEN CO., LTD.
    Date Received
    February 27, 2007
    Decision Date
    May 18, 2007
    Product Code
    NHA
    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
    NHA Abutment, Implant, Dental, Endosseous

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