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

    Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)

    K Number: K240508 · Decision Apr 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    40
    Same Product Code
    49
    Applicant Total
    5
    Review Days
    58

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    Basic Information

    Device Name
    Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
    K Number
    K240508
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Laclede, Inc.
    Date Received
    February 21, 2024
    Decision Date
    April 19, 2024
    Product Code
    LFD
    Advisory Committee
    Unknown
    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
    LFD Saliva, Artificial

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    Other Clearances by Laclede, Inc.

    K Number Device Name
    K180680 Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
    K162235 LUVENA VAGINAL MOISTURIZER & LUBRICANT
    K150841 Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant
    K061331 ORAL BALANCE LIQUID/ GEL