BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BENDA WEDGE

    K Number: K140144 · Decision Jul 8, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    265
    Registration Numbers
    265
    Same Product Code
    7
    Applicant Total
    45
    Review Days
    167

    Basic Information

    Device Name
    BENDA WEDGE
    K Number
    K140144
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CENTRIX, INC.
    Date Received
    January 22, 2014
    Decision Date
    July 8, 2014
    Product Code
    EJB
    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
    EJB Handle, Instrument, Dental

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