BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    GBT Machine Airflow Prophylaxis Master

    K Number: K253254 · Decision Jan 28, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    28
    Review Days
    121

    Basic Information

    Device Name
    GBT Machine Airflow Prophylaxis Master
    K Number
    K253254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E.M.S Electro Medical Systems S.A
    Date Received
    September 29, 2025
    Decision Date
    January 28, 2026
    Product Code
    ELC
    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
    ELC Scaler, Ultrasonic

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