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510(k) Data Aggregation

    K Number
    K220816
    Device Name
    BruxZir NOW
    Manufacturer
    Prismatik Dentalcraft, Inc.
    Date Cleared
    2022-08-02

    (134 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K130924,K203590
    Why did this record match?
    Reference Devices :

    K130924

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    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

    The provided text describes the regulatory clearance of a dental material, BruxZir® NOW, and its comparison to a predicate device, Perfit FS Dental Zirconia Fully Sintered Block. The information primarily focuses on demonstrating substantial equivalence rather than a study proving the device meets acceptance criteria in the context of an AI/ML device.

    However, I can extract the relevant performance data and acceptance criteria as described for the dental material itself. The document does not describe an AI/ML device, an MRMC study, or a standalone algorithm performance study. It's about a physical dental material.

    Here's the information based on the provided text, interpreted for the dental material:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (ISO/ASTM Standards)BruxZir® NOW Performance
    Flexural Strength:>800 MPa
    Type II Class 5 per ISO 6872:2015/Amd 1:2018 (>800 MPa)
    Solubility:**
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