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    K Number
    K030884
    Device Name
    APTUS BLUE
    Manufacturer
    ACADENTAL
    Date Cleared
    2003-05-27

    (68 days)

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

    ACADENTAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Aptus Blue is used in the cleansing of the root canal preparation during endodontic therapy.
    Device Description
    Aptus Blue is a 3cc endodontic syringe containing EDTA solution. Aptus Blue allows for cleansing action that facilitates easy removal of vital pulp tissue and necrotic tissue from the root canal. It is designed to be used with endodontic irrigation solutions and sodium hypochlorite solutions.
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