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FDA 510(k) Application Details - K241715
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K241715
Device Name
Powder, Porcelain
Applicant
Aidite (Qinhuangdao) Technology Co., Ltd.
No.9 Dushan Rd, Economic and Technological Development Zone
Qinhuangdao 066004 CN
Other 510(k) Applications for this Company
Contact
Jinzhong Xu
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
06/14/2024
Decision Date
07/12/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K241715
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