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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K253324
Device Name UltraPrint-Dental Denture UV
Applicant
Guangzhou Heygears IMC., Inc.
Block B2, 501, 601, Enterprise Accelerator
Kaifa District
Guangzhou,  CN 510700
Applicant Contact Mingyang Qu
Correspondent
Guangzhou Heygears IMC., Inc.
Block B2, 501, 601, Enterprise Accelerator
Kaifa District
Guangzhou,  CN 510700
Correspondent Contact Mingyang Qu
Regulation Number872.3760
Classification Product Code
EBI  
Date Received09/30/2025
Decision Date 11/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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