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510(k) Data Aggregation

    K Number
    K213425
    Device Name
    BruxZir Esthetic
    Manufacturer
    Prismatik Dentalcraft, Inc.
    Date Cleared
    2021-11-17

    (27 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K130924
    Why did this record match?
    Device Name :

    BruxZir Esthetic

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

    The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

    Device Description

    BruxZir® Esthetic blanks are zirconia milling blanks used for the production of esthetic zirconia dental restorations. The high esthetics and high strength of BruxZir® Esthetic restorations make them viable for use in all regions of the mouth. The manufactured dental restorations are made utilizing a CAD/CAM system for design and manufacture. The designed and manufactured dental restorations are then sintered at a high temperature. BruxZir® Esthetic blanks are available in white and pre-shaded varieties that can be easily adjusted to match the final shade.

    AI/ML Overview

    This document describes the premarket notification (510(k)) for the BruxZir® Esthetic device, a dental ceramic material. The focus is on demonstrating its substantial equivalence to a predicate device, which usually involves performance testing against established standards.

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Material Properties:
    Flexural Strength: >800 MPa (ISO 6872:2015/Amd 1:2018, Type II, Class 5)Average flexural strength of each worst-case block batch tested yielded results above 800 MPa minimum.
    Density: >6.05 g/cm³>6.05 g/cm³ (Listed as "Same" with predicate, implying this was met)
    Coefficient of Thermal Expansion (CTE/25-500°C): 10-11x10⁻⁶/°C and a standard deviation of less than 0.5 x 10⁻⁶/°C (ISO 6872:2015/Amd 1:2018)Tests performed on high and low colorant extreme shades yielded CTE results within 10-11 x 10⁻⁶/°C and a standard deviation of less than 0.5 x 10⁻⁶/°C.
    Chemical Solubility:
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