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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 K222520
Device Name Zirconia Block
Applicant
Yilink (Tianjin) Biotechnology Co., Ltd.
No 9 Kaituo Rd., Balitai Town, Jinnan District
Tianjin,  CN 300350
Applicant Contact Yaqiong Zhu
Correspondent
Chenhe Medical Consulting Co., Ltd.
Rm. 113 7th Floor, Block B, Bldg. 1, # A 38
Zhongguancun St., Haidan District
Beijing,  CN 100080
Correspondent Contact Jennifer Liu
Regulation Number872.6660
Classification Product Code
EIH  
Date Received08/19/2022
Decision Date 11/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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