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510(k) Data Aggregation

    K Number
    K253798

    Validate with FDA (Live)

    Device Name
    UltraPrint-Dental Hard Splint UV
    Manufacturer
    Guangzhou Heygears IMC., Inc.
    Date Cleared
    2026-03-02

    (94 days)

    Product Code
    MQC
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K203000
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The UltraPrint-Dental Hard Splint UV device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners and retainers.

    Device Description

    UltraPrint-Dental Hard Splint UV is a light-curing resin based on acrylate, biocompatible, for the generative fabrication of splint for DLP printers with UV-LED 385 nm. The material is a polymer undergoes polymerization and cross-linking reaction under the action of photo-initiation when exposed to UV light, which makes the resin material polymerize to a solid state at high speed.

    AI/ML Overview

    N/A

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