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510(k) Data Aggregation

    K Number
    K253324

    Validate with FDA (Live)

    Device Name
    UltraPrint-Dental Denture UV
    Manufacturer
    Guangzhou Heygears Imc., Inc.
    Date Cleared
    2025-11-20

    (51 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K200461
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    UltraPrint-Dental Denture UV is indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures.

    UltraPrint-Dental Denture UV is intended for continuous use in the oral environment, exclusively for professional dental work.

    UltraPrint-Dental Denture UV can be used in combination with a 3D printer using a 385nm light source. A 3D-printer is not part of the device.

    Device Description

    The Subject device is a light-cured methacrylate-based resin used in 3D printers for the production of full or partial denture base. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of full or partial denture base.

    The Subject device is used within a validated manufacturing workflow to create the intended dental device. Dental devices fabricated using the Subject device are prescription-only devices.

    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.

    AI/ML Overview

    N/A

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