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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name x-ray, tomography, computed, dental
510(k) Number K200270
Device Name rainbow MCT
Dentium Co., Ltd (ICT Branch)
76, Changnyong-daero 256beon-gil, Yeongtong-gu
Suwon-Si,  KR 16229
Applicant Contact Sangwoo Lee
Mtech Group
7707 Fannin St. Ste 200, V111
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number892.1750
Classification Product Code
Date Received02/04/2020
Decision Date 04/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No