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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 K160483
Device Name Burn-out Cylinder and Angled Screw Abutments
Applicant
Dentium Co., Ltd.
150, Eondong-Ro
Giheung-Gu
Yongin-Si,  KR 443-270
Applicant Contact Sangpil Yoon
Correspondent
Dentium USA
6761 Katella Ave.
Cypress,  CA  90630
Correspondent Contact Younjung Yuk
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/22/2016
Decision Date 08/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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