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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 K250946
Device Name Denture Base Resin DT20
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
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number872.3760
Classification Product Code
EBI  
Date Received03/28/2025
Decision Date 03/31/2025
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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