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FDA 510(k) Application Details - K193622
Device Classification Name
Aligner, Sequential
More FDA Info for this Device
510(K) Number
K193622
Device Name
Aligner, Sequential
Applicant
Perfection Aligner System Hong Kong Limited
Flat/Rm 4B, 4/F, Hang Fat Industrial Building, 550-556
Castle Peak Road
Kowloon, HongKong HK
Other 510(k) Applications for this Company
Contact
Alwin Ngai
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
12/26/2019
Decision Date
07/06/2021
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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