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    K Number
    K253053
    Device Name
    Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
    Manufacturer
    Hangzhou SHINING3D Dental Technology Co., Ltd.
    Date Cleared
    2025-09-23

    (1 days)

    Product Code
    EBF,EBG,PZY
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K233596
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Dura-Crown is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. Dura-Crown is used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and bridge restorations. Dura-Crown can also be used for the fabrication of artificial teeth and temporary crowns & bridges.

    Device Description

    The product should be used in combination with SHINING3D printer. It is stored in 500ml HDPE bottle. The product is a liquid photo-curable material, which is produced by free radical polymerization of oligomers triggered by a photoinitiator contained in the resin. Automated printing of the resin in multiple layers, each light-cured before adding next layer, are post cured in the cure device. The product is intended exclusively for professional dental work.

    AI/ML Overview

    N/A

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