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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 K261261
Device Name Dura-Arch
Applicant
Hangzhou SHINING3D Dental Technology Co., Ltd.
9-5-2, Tri-River Valley, Wenyan St., Xiaoshan
Hangzhou,  CN 311258
Applicant Contact Yuqi Chen
Correspondent
Third Party Review Group, LLC
1887 Whitney Mesa Dr.
Suite 1960
Henderson,  NV  89014
Correspondent Contact Dave Yungvirt
Regulation Number872.3770
Classification Product Code
EBG  
Subsequent Product Code
PZY  
Date Received04/16/2026
Decision Date 04/17/2026
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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