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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 K170384
Device Name Dentium NR Line CAD/CAM Abutments
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 Received02/07/2017
Decision Date 08/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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