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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K223192
Device Name XT Stain/Glaze
Applicant
Shenzhen Xiangtong Co., Ltd.
2nd Floor, 1st Bldg., W. Area, Honghualing Industrial
Park, #88, N. Zhuguang Rd.
Shenzhen,  CN 518055
Applicant Contact Xue Gong
Correspondent
Shenzhen Xiangtong Co., Ltd.
2nd Floor, 1st Bldg., W. Area, Honghualing Industrial
Park, #88, N. Zhuguang Rd.
Shenzhen,  CN 518055
Correspondent Contact Xue Gong
Regulation Number872.6660
Classification Product Code
EIH  
Date Received10/13/2022
Decision Date 03/27/2023
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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