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

    EDS Universal Cement

    K Number: K152691 · Decision Feb 25, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    17
    Review Days
    157

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    Basic Information

    Device Name
    EDS Universal Cement
    K Number
    K152691
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Essential Dental Systems, Inc.
    Date Received
    September 21, 2015
    Decision Date
    February 25, 2016
    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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