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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 K211795
Device Name EzDent-i/ E2/ Prora View/ Smart M Viewer
Ewoosoft Co., Ltd.
801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil
hwaseong-si,  KR 18449
Applicant Contact young seok kim
Lk Consulting Group USA, Inc.
18881 Von Karman Ave. STE 160
irvine,  CA  92612
Correspondent Contact priscilla chung
Regulation Number892.2050
Classification Product Code
Date Received06/10/2021
Decision Date 10/04/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No