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510(k) Data Aggregation

    K Number
    K213643
    Device Name
    UltraPrint-Dental Temp C&B UV
    Date Cleared
    2022-01-14

    (57 days)

    Product Code
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Heygears Imc. Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    UltraPrint-Dental Temp C&B UV is indication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is not more than 28 days in oral environment.
    Device Description
    The Subject device is a light-cured methacrylate-based resin used in 3D printers for the production of temporary dental restorations. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of temporary dental restorations. Restorations fabricated using the Subject device are one-time use, temporary, prescription-only devices. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigments. Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical and biocompatible properties. The Subject device is intended to be sold by the bottle and used with compatible hardware 3D printers and their nesting software, and post-curing devices.
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