BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    ENA CEM

    K Number: K062355 · Decision Dec 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    6
    Review Days
    135

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ENA CEM
    K Number
    K062355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micerium S.P.A.
    Date Received
    August 14, 2006
    Decision Date
    December 27, 2006
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EMA), ordered by most recent decision date.

    G-CEM UNIVERSAL

    FDA 510(k)
    FDA Class 2 ·Dental

    REGEN Bioactive Cement

    FDA 510(k)
    FDA Class 2 ·Dental

    Bifix Veneer LC, Bifix Veneer Try-In

    FDA 510(k)
    FDA Class 2 ·Dental

    iCEM Universal Plus

    FDA 510(k)
    FDA Class 2 ·Dental

    TopCEM Vigor SA Self-Adhesive Resin Cement

    FDA 510(k)
    FDA Class 2 ·Dental

    GlasIonomer FX-LC

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Micerium S.P.A.

    K Number Device Name
    K103474 ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
    K072978 TENDER ORTHO BOND-ENA BOND-ENA ETCH
    K063170 TENDER FIBER
    K062367 MINISCREWS ANCHORING SYSTEM, M.A.S.
    K062906 ENA HFO COMPOSITE SYSTEM