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    K Number
    K252446
    Device Name
    BruxZir® NOW
    Manufacturer
    Prismatik Dentalcraft, Inc.
    Date Cleared
    2025-09-03

    (30 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K220816
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

    Contraindication: BruxZir® NOW Bridge Block design is limited to a maximum of four units with a maximum of two pontics between pillars.

    Device Description

    BruxZir® NOW is a pre-shaded, fully sintered zirconia CAD/CAM block used for fabricating single-unit or multiple-unit dental restorations. BruxZir® NOW is used for fabricating single-unit dental restorations, while BruxZir® NOW Bridge Block is used for fabricating multiple-unit dental restorations. BruxZir® NOW is available in the following shades: Bleach White, Bleach 1, Bleach 3, and 16 VITA Classical shades (A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4). BruxZir® NOW Bridge Block is available in the following 6 VITA Classical shades: A1, A2, A3, B1, C2, D2. The method of fabricating the restoration is with CAD/CAM milling systems.

    AI/ML Overview

    N/A

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