BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇪 Germany

    ENDOSTEPPER 1

    K Number: K993188 · Decision Sep 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    1
    Review Days
    5

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    Basic Information

    Device Name
    ENDOSTEPPER 1
    K Number
    K993188
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phytron- Elektronik GmbH
    Date Received
    September 23, 1999
    Decision Date
    September 28, 1999
    Product Code
    EKX
    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
    EKX Handpiece, Direct Drive, Ac-Powered

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