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510(k) Data Aggregation

    K Number
    K053166
    Device Name
    SINCLAIR ORAL RINSE
    Date Cleared
    2006-05-17

    (184 days)

    Product Code
    Regulation Number
    872.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    SINCLAIR PHARMACEUTICALS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SINCLAIR ORAL RINSE helps to prevent and reduce gingivitis, when used as directed. SINCLAIR ORAL RINSE serves as an adjunct to normal mechanical oral hygiene where this has proved inadequate.
    Device Description
    SINCLAIR ORAL RINSE contains Delmopinol hydrochloride, an anti-plaque agent that presents a surface barrier preventing oral bacteria from adhering to and colonizing on tooth surfaces and forming dental plaque. SINCLAIR ORAL RINSE helps prevent the binding of bacteria to the tooth surfaces, thereby interfering with the primary steps of plaque formation.
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    K Number
    DEN050001
    Device Name
    DECAPINOL ORAL RINSE
    Date Cleared
    2005-04-18

    (84 days)

    Product Code
    Regulation Number
    872.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    SINCLAIR PHARMACEUTICALS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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