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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K192436
Device Name Healing Abutments and Cover Screws
Applicant
Dentium Co., Ltd.
150, Eondong-Ro
Giheung-Gu
Yongin-Si,  KR 446-914
Applicant Contact Byung-sun Kim
Correspondent
Dentium Co., Ltd.
150, Eondong-Ro
Giheung-Gu
Yongin-Si,  KR 446-914
Correspondent Contact Byung-sun Kim
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/06/2019
Decision Date 01/23/2020
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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