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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 K170894
Device Name Zirconia Dental Ceramics
Applicant
Chengdu Besmile Biotechnology Co., Ltd.
#1666, Chenglong Rd. Section Two,
Economic-Technical Development Zone
Chengdu,  CN 610100
Applicant Contact Moushan Liu
Correspondent
Chengdu Besmile Biotechnology Co., Ltd.
#1666, Chenglong Rd. Section Two,
Economic-Technical Development Zone
Chengdu,  CN 610100
Correspondent Contact Moushan Liu
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/27/2017
Decision Date 08/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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