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510(k) Data Aggregation

    K Number
    K041023
    Device Name
    STAY-PUT IMPREGNATED
    Manufacturer
    COLTENE/WHALEDENT GMBH & CO. KG
    Date Cleared
    2004-06-15

    (56 days)

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

    **COLTENE/WHALEDENT GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stay-put impregnated are polyester cords impregnated with aluminium chloride hexahydrate for the temporary retraction and haemostasis of the gingival margin.
    Device Description
    Stay-put impregnated is a retraction cord with a metal core and impregnated with Aluminium chloride Hexahydrate.
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    K Number
    K032662
    Device Name
    GUTTAFLOW
    Manufacturer
    COLTENE/WHALEDENT GMBH & CO. KG
    Date Cleared
    2003-11-03

    (67 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    **COLTENE/WHALEDENT GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GuttaFlow is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.
    Device Description
    GuttaFlow is a Class II, permanent root canal filling material. GuttaFlow is silicone based (Polydimethysiloxane) and consists additionally of Gutta Percha, Zinc oxide, Zircondioxide, paraffin-based oil, silicone oil, hexachloroplatinic acid, and silicic acid.
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