BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EMS AIR-FLOW HANDY PERIO

    K Number: K092289 · Decision Oct 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    28
    Review Days
    83

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    Basic Information

    Device Name
    EMS AIR-FLOW HANDY PERIO
    K Number
    K092289
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E.M.S Electro Medical Systems S.A
    Date Received
    July 29, 2009
    Decision Date
    October 20, 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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