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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    MERON PLUS

    K Number: K063554 · Decision Jan 12, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    495
    Applicant Total
    94
    Review Days
    46

    Basic Information

    Device Name
    MERON PLUS
    K Number
    K063554
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VOCO GMBH
    Date Received
    November 27, 2006
    Decision Date
    January 12, 2007
    Product Code
    EMA
    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
    EMA Cement, Dental

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