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

    HUBUKA HYG TOOTHBRUSH

    K Number: K915576 · Decision Mar 4, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    813

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    Basic Information

    Device Name
    HUBUKA HYG TOOTHBRUSH
    K Number
    K915576
    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
    December 12, 1991
    Decision Date
    March 4, 1994
    Product Code
    MMD
    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
    MMD Toothbrush, Ionic, Battery-Powered

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    Other Clearances by Hukuba Dental Corp.

    K Number Device Name
    K945248 HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH