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

    CONTRA-ANGLE HANDPIECE KOMET OS30

    K Number: K090548 · Decision Jun 30, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    18
    Review Days
    120

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    Basic Information

    Device Name
    CONTRA-ANGLE HANDPIECE KOMET OS30
    K Number
    K090548
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W&H Dentalwerk Buermoos GmbH
    Date Received
    March 2, 2009
    Decision Date
    June 30, 2009
    Product Code
    EFB
    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
    EFB Handpiece, Air-Powered, Dental

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