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

    iCEM Universal Plus

    K Number: K254063 · Decision Dec 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    7
    Review Days
    2

    Basic Information

    Device Name
    iCEM Universal Plus
    K Number
    K254063
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kulzer, LLC
    Date Received
    December 17, 2025
    Decision Date
    December 19, 2025
    Product Code
    EMA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    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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