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510(k) Data Aggregation

    K Number
    K070591
    Device Name
    REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH
    Manufacturer
    UNION DENTAL S.A./UNIDESA.ODI
    Date Cleared
    2007-05-11

    (71 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNION DENTAL S.A./UNIDESA.ODI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Teeth for the fabrication of dentures These teeth are used for making full or partial dentures. The These toon are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patients mouth and is a removable. It is not implanted.
    Device Description
    A preformed plastic denture tooth is a prefabricated device, composed of Polymethyl Methacrylate. The teeth are made up of several different acrylic resins that form the layers of enamel, dentine and neck, all of which are created using the polymerization of acrylic monomers, reticulant agents, resins and non-toxic pigments that form a unique composition, which with the union of the layers produces a compact whole that looks and behaves in a similar wav to real teeth. Once the polymerization process has been carried out, the teeth are obtained and the next step is to remove any burrs and polish them. They are then mounted in the presentation units with the relevant product details (brand, model, colour and batch).
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