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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K253798
Device Name UltraPrint-Dental Hard Splint UV
Applicant
Guangzhou Heygears IMC., Inc.
Block B2, 501,601, Enterprise Accelerator, Kaifa District
Guangzhou,  CN 510700
Applicant Contact Meifang Liu
Correspondent
Guangzhou Heygears IMC., Inc.
Block B2, 501,601, Enterprise Accelerator, Kaifa District
Guangzhou,  CN 510700
Correspondent Contact Meifang Liu
Classification Product Code
MQC  
Subsequent Product Code
KMY  
Date Received11/28/2025
Decision Date 03/02/2026
Decision Substantially Equivalent (SESE)
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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