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510(k) Data Aggregation

    K Number
    K253953

    Validate with FDA (Live)

    Date Cleared
    2026-03-10

    (90 days)

    Product Code
    Regulation Number
    872.6660
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Indications for Use

    • Missing tooth structure in anterior and posterior teeth
    • Partial edentulism in the anterior and posterior region

    Types of restorations

    • Crowns
    • 3-unit bridges
    • Multi-unit bridges with 2 connected pontics
    • Multi-unit bridges with up to 4 connected anterior pontics
    • Cantilever bridges with one pontic
    • Adhesive bridges
    • Hybrid bridges
    • Hybrid structures and hybrid crowns
    • Inlays
    • Onlays
    • Veneers
    Device Description

    IPS e.max® Zirconia is a yttrium-stabilized zirconium oxide for the fabrication of fixed all-ceramic restorations according to ISO 6872:2024 Type 2, Class 5. Dental restorations are milled out of the zirconia discs through the CAD/CAM process. The zirconia restorations can be stained and characterized, before or after the final sintering process. The IPS e.max Zirconia Color Liquids/IPS e.max Zirconia Effect Liquids are ready-to-use solutions that burn out without leaving residue for the visible staining and characterization of unsintered zirconium oxide restorations.

    IPS e.max Zirconia is available in Discs with a diameter of 98.5 mm width and various thickness and shades and Liquids: dipping and brushing liquids, diluter, effect liquid, opaque

    AI/ML Overview

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