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

    BioSonic US200 Ultrasonic Scaler (60034537)

    K Number: K240801 · Decision Jul 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    4
    Review Days
    98

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    Basic Information

    Device Name
    BioSonic US200 Ultrasonic Scaler (60034537)
    K Number
    K240801
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dent4you AG
    Date Received
    March 25, 2024
    Decision Date
    July 1, 2024
    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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