BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    SINCLAIR ORAL RINSE

    K Number: K053166 · Decision May 17, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    184

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    Basic Information

    Device Name
    SINCLAIR ORAL RINSE
    K Number
    K053166
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5580
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sinclair Pharmaceuticals Limited
    Date Received
    November 14, 2005
    Decision Date
    May 17, 2006
    Product Code
    NTO
    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
    NTO Rinse, Oral, Antibacterial (By Physical Means)

    Similar 510(k) Clearances

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    Other Clearances by Sinclair Pharmaceuticals Limited

    K Number Device Name
    DEN050001 DECAPINOL ORAL RINSE