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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 K212765
Device Name Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Applicant
Bloomden Bioceramics (Hunan) Co., Ltd.
#301, 5th Bldg., Hi-Tech Int'L Enterprise Port
Liandong U Valley, Linyu Rd.
Changsha,  CN 410000
Applicant Contact Shengyong Liao
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A
Zhongguan Times Square Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Grace Liu
Regulation Number872.6660
Classification Product Code
EIH  
Date Received08/31/2021
Decision Date 11/15/2021
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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