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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 K231884
Device Name TRIOCLEAR System
Applicant
Modern Dental Laboratory (DG) Co., Ltd.
Room 102&1102 & Floor 4-10, Block 1 Modern Dental Industrial
Park, No.7 Nantou, Songshan Lake Hi-Tech Industrial Zone
Dongguan,  CN 523000
Applicant Contact Robin Liu
Correspondent
Modern Dental Laboratory Co., Ltd.
Block 1 Modern Dental Industrial Park No.7 Nantou,
Songshan Lake Hi-Tech Industrial Zone
Dongguan,  CN 523000
Correspondent Contact Robin Liu
Regulation Number872.5470
Classification Product Code
NXC  
Date Received06/27/2023
Decision Date 09/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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