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FDA 510(k) Application Details - K213570
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K213570
Device Name
Powder, Porcelain
Applicant
Aidite (Qinhuangdao) Technology Co., Ltd.
No.9 Dushan Road,Economic and Technological
Development Zone,
Qinhuangdao 066004 CN
Other 510(k) Applications for this Company
Contact
Wang Lili
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
11/10/2021
Decision Date
01/07/2022
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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