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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 K160670
Device Name ET US SS Prosthetic system
Applicant
OSSTEM IMPLANT CO., LTD.
#507-8 GEOJE3-DONG
YEONJE-GU
Busan,  KR 611-804
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 Received03/10/2016
Decision Date 04/25/2017
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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