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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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