BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Venus Bulk Flow ONE

    K Number: K220605 · Decision Apr 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    7
    Review Days
    50

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    Basic Information

    Device Name
    Venus Bulk Flow ONE
    K Number
    K220605
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kulzer, LLC
    Date Received
    March 2, 2022
    Decision Date
    April 21, 2022
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

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