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

    AIR-FLOW MASTER STANDARD

    K Number: K073284 · Decision Dec 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    5
    Review Days
    23

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    Basic Information

    Device Name
    AIR-FLOW MASTER STANDARD
    K Number
    K073284
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    (Ems Sa) Electro Medical Systems
    Date Received
    November 21, 2007
    Decision Date
    December 14, 2007
    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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    Other Clearances by (Ems Sa) Electro Medical Systems

    K Number Device Name
    K032099 SWISS MASTER LIGHT
    K992504 EMS KERMIT
    K991874 EMS SURFACE MOUNT SCALER
    K991588 EMS SWISS ORTHOCLAST