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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 K231181
Device Name bright CT
Applicant
Dentium Co., Ltd (ICT Branch)
76, Changnyong-daero 256beon-gil, Yeongtong-gu,
Suwon-si,  KR 16229
Applicant Contact Sang Woo Lee
Correspondent
Mtech Group
7505 Fannin St. Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number892.1750
Classification Product Code
OAS  
Date Received04/26/2023
Decision Date 12/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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