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510(k) Data Aggregation

    K Number
    K173971
    Device Name
    K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent
    Date Cleared
    2018-11-15

    (321 days)

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

    Yeti Dentalprodukte Gmbh

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Zircon Blanks are used for milling using digital stl-files to produce Crowns, Bridges and monolithic works. We propose the K2 Zircon Blanks for anterior and posterior restorations. Table 1: Indication of use and maximum intermediate elements. | | Single crown | | Bridges | | |----------------------------------------|--------------|-----------|----------|-----------| | | Anterior | Posterior | Anterior | Posterior | | K2 Zircon Blank<br>white classic | X | X | 2 | 2 | | K2 Zircon Blank<br>translucent | X | X | 2 | 2 | | K2 Zircon Blank<br>extreme translucent | X | X | 1 | - | All K2 Zircon Blanks are indicated to be colored with Dip & Brush K2 CAD CAM Zircon Liquids. K2 Zircon Blanks should be not used by the general public or over-the-counter.
    Device Description
    The Yeti K2 Zircon Blanks are ceramic blanks, which are indicated for the production of dentalprosthetic restorations. The blanks named above can be machined with CAM, CAD/CAM or copy milling systems commonly used in dental medical technology and for milling using digital STL files to produce Crowns, Bridges and monolithic works made from zirconium oxide. The Yeti Dip & Brush K2 liquids are ready for use water-based products. These liquids are specifically formulated for the colorization of K2 Zircon Blanks from Yeti Dentalprodukte GmbH.
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