BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge

    K Number: K232393 · Decision Oct 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    79

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    Basic Information

    Device Name
    BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge
    K Number
    K232393
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Proedge Dental Products, Inc.
    Date Received
    August 9, 2023
    Decision Date
    October 27, 2023
    Product Code
    QYJ
    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
    QYJ Dental Waterline Treatment Cartridge