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

    SALIVA SUBSTITUTE

    K Number: K822971 · Decision Nov 16, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    40
    Same Product Code
    49
    Applicant Total
    1
    Review Days
    39

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SALIVA SUBSTITUTE
    K Number
    K822971
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Roxane Laboratories, Inc.
    Date Received
    October 8, 1982
    Decision Date
    November 16, 1982
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LFD), ordered by most recent decision date.

    Allday Moisturizing Rinse

    FDA 510(k)
    FDA Unclassified ·Unknown

    CloSYS® Dry Mouth Sensitive Mouth Rinse

    FDA 510(k)
    FDA Unclassified ·Unknown

    Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)

    FDA 510(k)
    FDA Unclassified ·Unknown

    Caphosol® Artifical Saliva (32 doses sachet box)

    FDA 510(k)
    FDA Unclassified ·Unknown

    GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray

    FDA 510(k)
    FDA Unclassified ·Unknown

    Dentilube Spray

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all