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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K260170
Device Name LumiCera
Applicant
Hangzhou SHINING3D Dental Technology Co., Ltd.
9-5-2, Tri-River Valley, Wenyan St., Xiaoshan
Hangzhou,  CN 311258
Applicant Contact Yuzhuo Wang
Correspondent
Third Party Review Group, LLC
7 Giralda Farms, Suite 120a
Madison,  NJ  07940
Correspondent Contact Dave Yungvirt
Regulation Number872.3690
Classification Product Code
EBF  
Date Received01/20/2026
Decision Date 01/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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