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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 K160828
Device Name Dentium Implantium & SuperLine Prosthetics
Applicant
DENTIUM CO., LTD.
150, EONDONG-RO, GIHEUNG-GU
Yongin-si,  KR 443-270
Applicant Contact Sangpil Yoon
Correspondent
DENTIUM CO., LTD.
150, EONDONG-RO, GIHEUNG-GU
Yongin-si,  KR 443-270
Correspondent Contact Sangpil Yoon
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/25/2016
Decision Date 09/15/2016
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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