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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K160666
Device Name Dentiq3D
Applicant
3D Industrial Imaging Co., Ltd.
413 Institute Of Computer Technology
Seoul National University, Daehak-Dong,
Gwanak-Gu,  KR
Applicant Contact Jin Sa Kim
Correspondent
LK Consulting Group USA, Inc.
800 Roosevelt Suite 110
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/09/2016
Decision Date 10/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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