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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 K212259
Device Name Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Applicant
Zirdent New Material Co., Ltd.
#101,3rd Bldg. Of Hai Ping International Medical Device
Industrial Area, #229, Guyuan Rd., Hi-Tech New District
Changsha,  CN 410205
Applicant Contact Jia Li
Correspondent
Guangzhou Junyi Information Technology Co., Ltd.
Rm. 304, Bldg. A, # 62 Nanyun 2nd Rd., Science Town
Huangpu District, Guangzhou City,  CN 510663
Correspondent Contact Jinghua Zhou
Regulation Number872.6660
Classification Product Code
EIH  
Date Received07/20/2021
Decision Date 11/12/2021
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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