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

    PLUSTRON ION TOOTHBRUSH SYSTEM

    K Number: K971639 · Decision Jun 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    53

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    Basic Information

    Device Name
    PLUSTRON ION TOOTHBRUSH SYSTEM
    K Number
    K971639
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6865
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sas Group, Inc.
    Date Received
    May 2, 1997
    Decision Date
    June 24, 1997
    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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