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

    STROBEX ULTRON ELECTROSURGE-DENTAL UNIT

    K Number: K850666 · Decision May 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    18
    Applicant Total
    23
    Review Days
    98

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    Basic Information

    Device Name
    STROBEX ULTRON ELECTROSURGE-DENTAL UNIT
    K Number
    K850666
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4920
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Ipco Corp.
    Date Received
    February 20, 1985
    Decision Date
    May 29, 1985
    Product Code
    EKZ
    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
    EKZ Unit, Electrosurgical, And Accessories, Dental

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