BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇯🇵 Japan

    HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH

    K Number: K945248 · Decision Jan 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    343
    Registration Numbers
    344
    Same Product Code
    53
    Applicant Total
    2
    Review Days
    91

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    Basic Information

    Device Name
    HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH
    K Number
    K945248
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6865
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hukuba Dental Corp.
    Date Received
    October 27, 1994
    Decision Date
    January 26, 1995
    Product Code
    JEQ
    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
    JEQ Toothbrush, Powered

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    Other Clearances by Hukuba Dental Corp.

    K Number Device Name
    K915576 HUBUKA HYG TOOTHBRUSH