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FDA 510(k) Application Details - K223517
Device Classification Name
Aligner, Sequential
More FDA Info for this Device
510(K) Number
K223517
Device Name
Aligner, Sequential
Applicant
Wuxi EA Medical Instruments Technologies Limited.
No.1619 Huishan Avenue, Huishan Economic Development Zone
Wuxi CN
Other 510(k) Applications for this Company
Contact
Jessica Luo
Other 510(k) Applications for this Contact
Regulation Number
872.5470
More FDA Info for this Regulation Number
Classification Product Code
NXC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/23/2022
Decision Date
06/13/2023
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
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