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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 K261046
Device Name Dental Zirconia Blank & Coloring Liquid
Applicant
Hunan Qinghao Puzhong Technology Co., Ltd.
1-3f, Bldg. 2.2-F, Xinma Power Innovation Park, #899 Xianyue
Zhuzhou,  CN 412007
Applicant Contact Zhiquan Wang
Correspondent
Beijing Xinranyicheng Medicine & Technology Co., Ltd.
2-801-01, Floor 7, Bldg. 1, #168 Guanganmenwai St., Xicheng
Beijing,  CN 10053
Correspondent Contact Yuqing Yang
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/31/2026
Decision Date 07/17/2026
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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