BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    W&H HANDPIECE ANESTO, MODEL: RA-5

    K Number: K083811 · Decision Jan 14, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    10
    Applicant Total
    18
    Review Days
    388

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    Basic Information

    Device Name
    W&H HANDPIECE ANESTO, MODEL: RA-5
    K Number
    K083811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4475
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W&H Dentalwerk Buermoos GmbH
    Date Received
    December 22, 2008
    Decision Date
    January 14, 2010
    Product Code
    EGM
    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
    EGM Injector, Jet, Mechanical-Powered

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