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 a medical device manufactured by Guangzhou Heygears IMC., Inc.. It received FDA 510(k) clearance on 2026-03-02 under approval 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. It is manufactured by Guangzhou Heygears IMC., Inc.. The 510(k) number is K253798.
When was UltraPrint-Dental Hard Splint UV approved by the FDA?
UltraPrint-Dental Hard Splint UV received FDA 510(k) clearance on 2026-03-02, under approval number K253798.
What company makes UltraPrint-Dental Hard Splint UV?
UltraPrint-Dental Hard Splint UV is manufactured by Guangzhou Heygears IMC., Inc..
What is the FDA product code for UltraPrint-Dental Hard Splint UV?
The FDA product code for UltraPrint-Dental Hard Splint UV is MQC.
Related Clinical Trials
Other Devices by Guangzhou Heygears IMC., Inc.
Related Devices (Code: MQC)
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.