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510(k) Data Aggregation

    K Number
    K161025
    Device Name
    priti multidisc ZrO2 High Translucent
    Manufacturer
    PRITIDENTA GMBH
    Date Cleared
    2017-02-03

    (297 days)

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

    PRITIDENTA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    priti® multidisc ZrO2 High Translucent are pre-sintered zirconium oxide blanks for use in CNC (Computer Numerical Controls) milling machines to fabricate partial and single anterior and lateral crowns, bridges up to 3 units, inlays, onlays, and veneers for dental prostheses for restoration purposes only.
    Device Description
    The priti multidisc ZrOs High Translucent blanks are made of Yttria fully stabilized zirconia (5Y-FSZ Fully Stabilized Zirconia), whereby the increased translucency is due to the higher stabilization of the zirconia base powder with yttrium oxide (Y2O3). The priti®multidisc ZrO₂ High Translucent blanks are provided as round discs with a diameter of 98.5mm, and varying thicknesses along with 16 VITA color shades, and multicolor versions.
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