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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 K112045
Device Name SIMPLELINE II ABUTMENT SYSTEM
Applicant
Dentium Co., Ltd.
27-5 Leui-Dong, Yeongtong-Gu
Suwon-Si, Gyeonggi-Do,  KR 442-270
Applicant Contact JONGHYUN CHOI
Correspondent
Dentium Co., Ltd.
27-5 Leui-Dong, Yeongtong-Gu
Suwon-Si, Gyeonggi-Do,  KR 442-270
Correspondent Contact JONGHYUN CHOI
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/18/2011
Decision Date 01/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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