UltraPrint-Dental Denture UV
K-Number: K253324 · 2025-11-20
ApplicantGuangzhou Heygears IMC., Inc.
Decision Date2025-11-20
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
UltraPrint-Dental Denture UV is a medical device manufactured by Guangzhou Heygears IMC., Inc.. It received FDA 510(k) clearance on 2025-11-20 under approval number K253324. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UltraPrint-Dental Denture UV?
UltraPrint-Dental Denture UV is a medical device that received FDA 510(k) clearance on 2025-11-20. It is manufactured by Guangzhou Heygears IMC., Inc.. The 510(k) number is K253324.
When was UltraPrint-Dental Denture UV approved by the FDA?
UltraPrint-Dental Denture UV received FDA 510(k) clearance on 2025-11-20, under approval number K253324.
What company makes UltraPrint-Dental Denture UV?
UltraPrint-Dental Denture UV is manufactured by Guangzhou Heygears IMC., Inc..
What is the FDA product code for UltraPrint-Dental Denture UV?
The FDA product code for UltraPrint-Dental Denture UV is EBI.
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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.