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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K193622
FOIA Releasable 510(k) K193622
Device Name TRIOCLEAR System
Applicant
Perfection Aligner System Hong Kong Limited
Flat/Rm 4B, 4/F, Hang Fat Industrial Building, 550-556
Castle Peak Road
Kowloon, HongKong,  HK
Applicant Contact Alwin Ngai
Correspondent
Perfection Aligner System Hong Kong Limited
Flat/Rm 4B, 4/F, Hang Fat Industrial Building, 550-556
Castle Peak Road
Kowloon, HongKong,  HK
Correspondent Contact Alwin Ngai
Regulation Number872.5470
Classification Product Code
NXC  
Date Received12/26/2019
Decision Date 07/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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