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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 K192535
Device Name Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia
Applicant
Qinhuangdao Audental Metal Technology Co., Ltd.
Floor 2, 16 N. D, 1 Yanghe Rd., Development Area
Qinhuangdao,  CN 066004
Applicant Contact Wang Xi
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui
#5, Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/16/2019
Decision Date 01/31/2020
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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