BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇭 Switzerland

    AIR-FLOW PLUS Prophylaxis powder

    K Number: K171189 · Decision Sep 11, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    76
    Applicant Total
    28
    Review Days
    140

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    Basic Information

    Device Name
    AIR-FLOW PLUS Prophylaxis powder
    K Number
    K171189
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6030
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E.M.S Electro Medical Systems S.A
    Date Received
    April 24, 2017
    Decision Date
    September 11, 2017
    Product Code
    EJR
    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
    EJR Agent, Polishing, Abrasive, Oral Cavity

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