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510(k) Data Aggregation

    K Number
    K241131
    Device Name
    edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK
    Date Cleared
    2024-10-18

    (177 days)

    Product Code
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Edelweiss Dentistry Products GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    T-BLOCK and C-BLOCK are used for the following indications - -Crowns, inlays, onlays and veneers - -Implant-supported crowns The i-BLOCK is used for the following indication: - Implant-supported crowns -
    Device Description
    The edelweiss CAD/CAM BLOCK and the Ceramir CAD/CAM Block are hybrid glass blocks used for the fabrication of indirect single-tooth restorations using CAD/CAM technology. The edelweiss CAD/CAM BLOCK and the Ceramir CAD/CAM BLOCK are available in the three different variants T-BLOCK and i-BLOCK and five shades. T-BLOCKs are highly translucent blocks that mimic the optical properties of natural enamel. C-BLOCKs are high chromatic blocks corresponding to the color shades A0, A1, A2 and A3. i-BLOCKs are highly translucent and highly chromatic blocks, which have a pre-produced Ti-base interface. The uniqueness of the edelweiss CAD/CAM BLOCK and the Ceramir CAD/CAM BLOCK lies in the manufacturing process, in which a hybrid glass block is produced by the patented process of vitrification and laser sintering. As a result, the edelweiss CAD/CAM BLOCK and the Ceramir CAD/CAM BLOCK combines the properties of the current CAD/CAM systems in a single block. It has properties comparable to those of feldspar glass-ceramics.
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