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FDA 510(k) Application Details - K181816
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K181816
Device Name
Powder, Porcelain
Applicant
Qinhuangdao Silide Ceramic Technology Co., Ltd
No. 1 Yanghe Rd., Quinhuangdao Economic and Technological
Development Zone
Qinhuangdao 066000 CN
Other 510(k) Applications for this Company
Contact
Lou ChunHua
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/09/2018
Decision Date
11/29/2018
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
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