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510(k) Data Aggregation

    K Number
    K092231
    Device Name
    GEBDI TRIBOS 501
    Date Cleared
    2009-11-24

    (124 days)

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

    GEBDI DENTAL-PRODUCTS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.
    Device Description
    gebdi Tribos 501 artificial teeth devices are chemically based on polymethacrylate-polymers and their geod Thirddin tectif devices are enternitures are used when fabricating any kind of dental chemical properties. These provisional restaurations and/or removable dental prostheses at the dental laboratory only.
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