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510(k) Data Aggregation

    K Number
    K170050
    Device Name
    Z-CAD smile
    Manufacturer
    Metoxit AG
    Date Cleared
    2018-08-23

    (595 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Metoxit AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    METOXIT Z-CAD® smile blanks are indicated for the preparation of full ceramic crowns, inlays, veneers and 3 unit bridges in the anterior area. All white Z-CAD® smile blanks are indicated to be coloured with Z-CAD® Liquid smile-TC. The Z-CAD® Liquid smile-TC will be used to dye white pre-sintered zirconia restorations milled from Z-CAD® smile blanks in the dental field.
    Device Description
    Z-CAD® smile ceramic blanks are indicated for the production of dental-prosthetic restorations. The blanks named above can be machined with CAM, CAD/CAM or copy milling systems commonly used in dental medical technology to produce dental-prosthetic restorations made from zirconium oxide. This material offers excellent properties with regards to bio-compatibility, stability and aesthetics, which make it the material of choice for the production of restorations for dental crowns, inlays, onlays, veneers, and up to three unit bridges, which in turn combine the advantages of conventional casting technology and full ceramics. Dental technicians are therefore in a position to offer patients the extra added value when finishing the prosthesis. Metoxit Z-CAD® smile Blanks also includes Z-CAD® Liquids smile-TC. Z-CAD® Liquids smile-TC are ready for use water-based products, which are applied to the milled restauration prior to sintering to achieve individual shades. These liquids are specifically formulated for the dyeing of Z-CAD® smile blanks from Metoxit AG.
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    K Number
    K072569
    Device Name
    METOXIT CAM-BLANKS
    Manufacturer
    Metoxit AG
    Date Cleared
    2007-10-31

    (49 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Metoxit AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Metoxit blanks are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations. Limitations are listed in Table 1.
    Device Description
    Metoxit CAM-Blanks are dental ceramics, composed of yttrium-oxide stabilized tetragonal zirconium-oxide polycrystals. Metoxit CAM-Blanks are designed for the manufacturing of substructures for all-ceramic dental appliances. The dental appliance is machined either by CAD/CAM machining technique or the copying technique, then sintered to full density and strength and for the sole use of the particular patients. Metoxit CAM-Blanks are designed for the use as single tooth restorations or bridgeworks with up to two pontics in the anterior as well as in the posterior teeth region.
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