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FDA 510(k)

UltraPrint-Dental Hard Splint UV

K-Number: K253798 · 2026-03-02

ApplicantGuangzhou Heygears IMC., Inc.
Decision Date2026-03-02
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

UltraPrint-Dental Hard Splint UV is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Heygears IMC., Inc.. It received FDA 510(k) clearance on 2026-03-02 under 510(k) number K253798. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraPrint-Dental Hard Splint UV?

UltraPrint-Dental Hard Splint UV is a medical device that received FDA 510(k) clearance on 2026-03-02. The listed applicant is Guangzhou Heygears IMC., Inc.. The 510(k) number is K253798.

When did UltraPrint-Dental Hard Splint UV receive FDA 510(k) clearance?

UltraPrint-Dental Hard Splint UV received FDA 510(k) clearance on 2026-03-02, under 510(k) number K253798.

Who is the listed applicant for UltraPrint-Dental Hard Splint UV?

The FDA 510(k) record lists Guangzhou Heygears IMC., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraPrint-Dental Hard Splint UV?

The FDA product code for UltraPrint-Dental Hard Splint UV is MQC.

Other records listing Guangzhou Heygears IMC., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261626UltraPrint Flexible Denture UVK253324UltraPrint-Dental Denture UVK213643UltraPrint-Dental Temp C&B UV

Related Devices (Code: MQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250743Remvia NightGuardRemviaK251252NOBILCAM IMPAK DiscShandong Huge Dental Material CorporationK241729Hard Splint & Thermo-Adaptive SplintWhip Mix CorporationK243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLCK231775GR Resin System MSIPro3Dure Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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