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510(k) Data Aggregation

    K Number
    K243940
    Device Name
    VITA YZ Multi Translucent
    Manufacturer
    Vita Zahnfabrik H.Rauter GmbH & Co.
    Date Cleared
    2025-02-21

    (63 days)

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

    **Vita Zahnfabrik H.Rauter GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VITA YZ MULTI TRANSLUCENT is indicated for: - · fully anatomical anterior and posterior crowns - · fully anatomical 4 unit anterior and posterior bridges - · fully and partially veneered single tooth and up to 4-unit bridge substructures in the anterior and posterior tooth regions - · inlays - · Onlays - · veneers
    Device Description
    VITA YZ MULTI TRANSLUCENT are zirconia blanks for reliable shade reproduction. They can be used for the production of fully and partially veneered reconstructions and monolithic bridge restorations in the anterior and posterior tooth regions. VITA YZ MULTI TRANSLUCENT is part of the VITA YZ SOLUTIONS product group.
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    K Number
    K180703
    Device Name
    VITA YZ ST and VITA YZ XT
    Manufacturer
    VITA Zahnfabrik H.Rauter GmbH Co.
    Date Cleared
    2018-08-01

    (135 days)

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

    **VITA Zahnfabrik H.Rauter GmbH **Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VITA YZ® ST and VITA YZ® XT materials are blanks used for fabricating dental restorations. VITA YZ® ST is indicated for fully anatomical anterior crowns, multi-unit fully anatomical anterior and posterior bridges, fully anatomical crowns and multi-unit bridges on direct screw-retained restorations, and single-tooth and multi-unit bridge frameworks of anterior and posterior crowns and bridges. VITA YZ® XT is indicated for fully anatomical anterior and posterior crowns, fully anatomical 3-unit anterior and posterior bridges, and anterior and posterior single-tooth and 3-unit bridge frameworks.
    Device Description
    VITA YZ ST and VITA YZ XT discs are pre-sintered zirconia materials, partially stabilized with yttrium oxide (Y-TZP, yttria stabilized tetragonal zirconia polycrystal). VITA YZ ST is made of Super Translucent Zirconia and VITA YZ XT is made of Extra Translucent Zirconia. They offer higher translucency to better match natural dentition.
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