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

    SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET

    K Number: K900991 · Decision May 15, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    214
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    74

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    Basic Information

    Device Name
    SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET
    K Number
    K900991
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6510
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Tocad America, Inc.
    Date Received
    March 2, 1990
    Decision Date
    May 15, 1990
    Product Code
    EFS
    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
    EFS Unit, Oral Irrigation

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