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510(k) Data Aggregation

    K Number
    K111709
    Device Name
    FOUNDATION DENTAL RESIN
    Date Cleared
    2011-11-18

    (151 days)

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

    UNIX-JAPAN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Foundation Dental Resin is used to fabricate teeth and gums that are intended for use as removable full and partial dentures as well as occlusal splints and night guards. This dental resin material is used by dental professionals including dentists and dental technicians. They can be used to make various sizes, shapes, and color shades for anterior and posterior preformed plastic teeth. We are applying an approval as dental resin material as well as preformed product using this material. Foundation Dental Resin is intended for use by a qualified/trained dentists or dental laboratory technicians on dental plates for dentures (false teeth), temporary crowns, artificial teeth and orthodontic devices.
    Device Description
    Foundation Dental Resin material is a thermoplastic resin that is used to fabricate dental prosthesis. The resin is used in an injection molding or pressing device to fabricate the prostheses. Foundation Dental Resin, which is characterized by the fact that the principal component is a copolymer polypropylene.
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