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

    MAXCEM 2

    K Number: K073209 · Decision Jan 29, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    1
    Applicant Total
    32
    Review Days
    76

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    Basic Information

    Device Name
    MAXCEM 2
    K Number
    K073209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kerr Corporation
    Date Received
    November 14, 2007
    Decision Date
    January 29, 2008
    Product Code
    MZW
    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
    MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief

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