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510(k) Data Aggregation

    K Number
    K150432
    Device Name
    IDODENTINE DISC, IDODENTINE BLOCK
    Manufacturer
    UNION DENTAL S.A.
    Date Cleared
    2015-08-14

    (176 days)

    Product Code
    EBG, EBI, MQC
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNION DENTAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acrylic polymer blank particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM. Indications: - Temporary anterior and posterior crowns - Temporary anterior and posterior bridges with up to two adjacent pontics - Implant supported temporary restorations Maximum recommended usage period: 12 months - Removable structures for dentures (dental bases) - Removable structures for therapeutic restorations (bite splints or occlusal splints)
    Device Description
    Dental polymer blank is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a Cad-controlled milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blanks are available in a variety of shapes for different milling systems and are also available in variety of dental shades. Dental polymer blanks are made with the same material (Hot cured PMMA) that is used for the manufacture of the Union Dental artificial teeth brands ODILUX and ODIPAL (K070591). These polymer discs or blocks are especially suited for creating dental structures by means of milling CAD/CAM techniques commonly used in the dental laboratories and in dental practice. The elaboration is designed by a professional, a dental technician or a dentist. This quarantees their correct use, since it is an intermediate product in order to manufacture a custom-made product.
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    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

    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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