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510(k) Data Aggregation

    K Number
    K254283

    Validate with FDA (Live)

    Device Name
    BruxZir® Shaded 16 PLUS
    Manufacturer
    Prismatik Dentalcraft, Inc.
    Date Cleared
    2026-01-30

    (30 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Special
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K220816,K130924
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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 Shaded 16 PLUS blanks are used for the production of full-contour zirconia and zirconia-based substructures for crowns and bridges (restorations). Multiple thicknesses and shades (A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, BL1, BL3, and White) are available for milling into BruxZir restorations. The manufactured restorations are made utilizing the CAD/CAM system for design and manufacturing. The designed and manufactured restorations are then sintered and glazed. BruxZir Shaded 16 PLUS restorations are designed to match the body shade in the glazed state; however, precolor and stain should be applied if polychromatic (gingival to incisal) blending or other esthetic effects are desired. The sintered material exhibits maximum strength, color, and translucency similar to natural dentition.

    AI/ML Overview

    N/A

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