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    K Number
    K150423
    Device Name
    EXPAZEN
    Manufacturer
    PRODUITS DENTAIRES PIERRE ROLLAND (ACTEON GROUP)
    Date Cleared
    2015-07-08

    (139 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRODUITS DENTAIRES PIERRE ROLLAND (ACTEON GROUP)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EXPAZEN is a paste containing aluminum chloride which is intended to be used for temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
    Device Description
    EXPAZEN is a paste containing aluminum chloride.
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