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    K Number
    K983037
    Device Name
    ROEKO SEAL
    Manufacturer
    ROEKO ULM, ROESCHEISEN GMBH & CO.
    Date Cleared
    1998-10-20

    (50 days)

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

    **ROEKO ULM, ROESCHEISEN GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Roeko Seal root canal sealer is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling.
    Device Description
    Roeko Seal is a permanent root canal filling material, which is silicone based (Polydimethylsiloxane) and consists additionally of zircondioxide, paraffin-based oil silicone oil, hexachloroplatinic acid and silicic acid.
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