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510(k) Data Aggregation

    K Number
    K260170

    Validate with FDA (Live)

    Device Name
    LumiCera
    Manufacturer
    Hangzhou SHINING3D Dental Technology Co., Ltd.
    Date Cleared
    2026-01-21

    (1 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K222877
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LumiCera is used for fabricating permanent single crowns, permanent inlays and onlays, veneers, bridges.

    Device Description

    The product should be used in combination with SHINING3D printer. The product is a liquid photo-curable material, which is produced by free radical polymerization of oligomers triggered by photoinitiator contained in the resin. The resin is printed in multiple layers automatically, with each layer being subjected to light curing before the addition of the next layer, and then undergoes post-curing in a curing device. The product is intended exclusively for professional dental work.

    AI/ML Overview

    N/A

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