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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 K221051
Device Name Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Applicant
Changsha Honchon Technology Co., LTD
Room 627-628, Building 3th, Jinqiao Market Cluster Area 2,
Purui Road No.1555, Wangcheng
Changsha,  CN 410200
Applicant Contact Ling Li
Correspondent
Guangzhou Junyi Information Technology Co., Ltd.
Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town
Huangpu District, Guangzhou City,  CN 510663
Correspondent Contact Shanfeng Jiang
Regulation Number872.6660
Classification Product Code
EIH  
Date Received04/11/2022
Decision Date 07/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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