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510(k) Data Aggregation

    K Number
    K152215
    Device Name
    DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR
    Manufacturer
    Date Cleared
    2016-01-19

    (165 days)

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

    DENTALPLUS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DENTALOS PLUS discs are milling blanks consisting of Polymethylmethacrylate (PMMA) and designed for the fabrication of long-term temporary crown and bridgework. They are machined by use of the CAD/CAM technique. DENTALOS PLUS discs are recommended for manufacturing substructures of single tooth crowns and bridgeworks with up to two pontics.
    Device Description
    DENTALOS PLUS discs are milling blanks composed of hot cured polymethylmethacrylate (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 DENTALOS PLUS 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. DENTALOS PLUS discs are offered as monochrome discs (DENTALOS PLUS MONO) in nine different shades and as multicolored discs (DENTALOS PLUS MULTICOLOR) in five shades, all discs in different thicknesses.
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