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

    SONICWAVE SONIC PLAQUE REMOVER

    K Number: K012914 · Decision Oct 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    343
    Registration Numbers
    344
    Same Product Code
    53
    Applicant Total
    2
    Review Days
    32

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    Basic Information

    Device Name
    SONICWAVE SONIC PLAQUE REMOVER
    K Number
    K012914
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6865
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Homedics, Inc.
    Date Received
    August 30, 2001
    Decision Date
    October 1, 2001
    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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