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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K193341
Device Name iCTmotor (WL-1)
Applicant
Dentium Co., Ltd.
76, Changnyong-Daero 256beon-Gil, Yeongtong-Gu
Suwon-Si,  KR 16229
Applicant Contact Sangwoo Lee
Correspondent
Mtechgroup
7707 Fannin St. Suite 200 V111
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number872.4200
Classification Product Code
EBW  
Date Received12/03/2019
Decision Date 09/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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