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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 Bldg., 550-556
Castle Peak Rd.
Kowloon, Hongkong,  HK
Applicant Contact Alwin Ngai
Correspondent
Perfection Aligner System Hong Kong Limited
Flat/Rm 4b, 4/F, Hang Fat Industrial Bldg., 550-556
Castle Peak Rd.
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
Predetermined Change
Control Plan Authorized		 No
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