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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 K160519
Device Name Link Abutment for CEREC
Applicant
Osstem Implant Co., Ltd
66-16, Bansong-ro 513beon-gil, Haeundae-gu
Busan,  KR 612-070
Applicant Contact Hee Kwon
Correspondent
HIOSSEN INC.
85 BEN FAIRLESS DR.
FAIRLESS HILLS,  PA  19030
Correspondent Contact DAVID KIM
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/25/2016
Decision Date 10/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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