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

    PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER

    K Number: K023662 · Decision May 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    209

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    Basic Information

    Device Name
    PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER
    K Number
    K023662
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6855
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hwadong International Company , Ltd.
    Date Received
    October 31, 2002
    Decision Date
    May 28, 2003
    Product Code
    MCF
    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
    MCF Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile

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