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

    ESPE KETAC-ENDO APLICAP

    K Number: K911061 · Decision Jan 3, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    1
    Review Days
    298

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    Basic Information

    Device Name
    ESPE KETAC-ENDO APLICAP
    K Number
    K911061
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    H.A. Opotow Consulting
    Date Received
    March 11, 1991
    Decision Date
    January 3, 1992
    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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