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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K192847
Device Name AUTOLIGN
Applicant
Diorco Co., Ltd.
4f, 26 Yeongil-Ro, Yeongtong-Gu
Suwon-Si,  KR 16705
Applicant Contact Yongkyu Jin
Correspondent
Radios, LLC
4408 Tortuga Ln.
Mckinney,  TX  75070
Correspondent Contact Edward Park
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received10/03/2019
Decision Date 07/21/2020
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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