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510(k) Data Aggregation

    K Number
    K122025
    Device Name
    BRIGHTGLASS BRIGHTGLASS M
    Manufacturer
    KTK MEDICAL SUPPLIES GMBH
    Date Cleared
    2012-10-09

    (90 days)

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

    KTK MEDICAL SUPPLIES GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BRIGHTGLASS Discs are milling blanks consisting of Polymethylmethacrylate (PMMA) and designed for the fabrication of long-term temporary crown and bridgework. They are machined with the CAD/CAM technique. BRIGHTGLASS Discs are recommended for manufacturing substructures of single tooth crowns and bridgework with up to two pontics.
    Device Description
    BRIGHTGLASS discs are milling blanks composed of hot cured polymethymethacrylate (PMMA). They are intended to be used by dental professionals e.g. dental technicians for the fabrication of long-term temporary crowns and bridgeworks as custom-made restorations for the sole use of a particular patient. These restorations are designed virtually by dental technicians using the CAD technology on the basis of intraoral scans or scans from impressions and/or models. The designed restorations can thereafter be machined in all appropriate CAM Milling Centers out of BRIGHTGLASS Discs. In a further step the milled workpiece can be individually characterized with veneering materials and polished for to improve the aesthetic appearance of the finished restoration. BRIGHTGLASS discs are offered as monochromic disc (BRIGHT-GLASS) in six different shades and as multicolored disc (BRIGHT-GLASS M) in up to four shades, all discs in different thicknesses.
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