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    FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇹 Austria

    PROSTHODONTIC SCREWDRIVER , MODEL IA-400

    K Number: K100600 · Decision Jul 9, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    18
    Review Days
    128

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    Basic Information

    Device Name
    PROSTHODONTIC SCREWDRIVER , MODEL IA-400
    K Number
    K100600
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W&H Dentalwerk Buermoos GmbH
    Date Received
    March 3, 2010
    Decision Date
    July 9, 2010
    Product Code
    EKX
    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
    EKX Handpiece, Direct Drive, Ac-Powered

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