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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
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