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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 K230487
Device Name Dental Lithium Disilicate Glass-Ceramic
Applicant
Fuzhou Rick Brown Biomaterials Co., Ltd.
The First And Second Floors Of R&D Bldg., Jiecheng
Industrial Park, #36 Houshan Zhaishan, Nan
Fuzhou,  CN 350100
Applicant Contact Zhong Huang
Correspondent
Shenzhen Huatongwei International Inspection Co., Ltd.
1/F, Bldg. 5, Hongfa Hi-Tech Industrial Park
Tianliao, Guangming
Shenzhen,  CN 518107
Correspondent Contact Sherry Kang
Regulation Number872.6660
Classification Product Code
EIH  
Date Received02/23/2023
Decision Date 07/03/2023
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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