FDA 510(k) Application Details - K233016

Device Classification Name Powder, Porcelain

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510(K) Number K233016
Device Name Powder, Porcelain
Applicant Shenzhen Yurucheng Dental Materials Co., Ltd.
101-201, Building 4, No.1 Branch of Zhongcheng Life Science
Park, No. 14 Zhongxing Road, Xiuxin
Kengzi Street Office, Pingshan District, 518122 CN
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Contact Hongfei Liao
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 09/22/2023
Decision Date 12/21/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233016


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