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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 K172640
Device Name Dentium Implantium & SuperLine Prosthetics
Applicant
Dentium Co., Ltd.
150, Eondong-Ro, Giheung-Gu
Yongin-Si,  KR 16985
Applicant Contact Sangpil Yoon
Correspondent
Dentium Co., Ltd.
150, Eondong-Ro, Giheung-Gu
Yongin-Si,  KR 16985
Correspondent Contact Sangpil Yoon
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/01/2017
Decision Date 05/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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