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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K213643
Device Name UltraPrint-Dental Temp C&B UV
Applicant
Guangzhou Heygears IMC., Inc.
Block B2, 501, 601, Enterprise Accelerator
Kaifa District
Guangzhou,  CN 510700
Applicant Contact Lin Liu
Correspondent
Aclivi, LLC
3250 Brackley Dr.
Ann Abror,  MI  48105
Correspondent Contact Chris Brown
Regulation Number872.3770
Classification Product Code
EBG  
Date Received11/18/2021
Decision Date 01/14/2022
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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