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

    ORALUBE

    K Number: K090457 · Decision May 21, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    32
    Review Days
    87

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    Basic Information

    Device Name
    ORALUBE
    K Number
    K090457
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6375
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pulpdent Corporation
    Date Received
    February 23, 2009
    Decision Date
    May 21, 2009
    Product Code
    ONK
    Advisory Committee
    General Hospital
    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
    ONK Oral Lubricant

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