BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    Proxeo ULTRA (PB-510, PB-520 and PB-530)

    K Number: K223173 · Decision Jul 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    2
    Review Days
    276

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    Basic Information

    Device Name
    Proxeo ULTRA (PB-510, PB-520 and PB-530)
    K Number
    K223173
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W&H Dentalwerk Buermoss GmbH
    Date Received
    October 11, 2022
    Decision Date
    July 14, 2023
    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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    Other Clearances by W&H Dentalwerk Buermoss GmbH

    K Number Device Name
    K213221 AMADEO, M-UK1015 (incl. attachments and accessories)