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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, Gyeonggi-Do,  KR 16229
Applicant Contact Sang Woo Lee
Correspondent
Mtechgroup
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
Predetermined Change
Control Plan Authorized		 No
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