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    K Number
    K191926
    Device Name
    VITA VIONIC Bond
    Manufacturer
    VITA Zanhnfabrik H. Rauter GmbH Co.
    Date Cleared
    2020-01-29

    (195 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITA Zanhnfabrik H. Rauter GmbH Co.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VITA VIONIC® Bond is used to fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases.
    Device Description
    VITA VIONIC® Bond is a two-component glue, mainly composed of acrylate polymers based on methyl methacrylate and used to fix artificial teeth in the milled denture base. VITA VIONIC® component I comes in a glass jar with a screw top lid and VITA VIONIC® Bond component II comes in a glass bottle with a screw top cap. Component II is mixed into component I by stirring until no streaks are visible. A thin film is then applied to all Bonding surfaces and then the artificial teeth are placed into the denture base and VITA VIONIC® Bond is allowed to cure. Comes in one, colorless shade. This product is provided non-sterile.
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