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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K161604
Device Name OSSTEM Implant System
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.
Fariless Hills,  PA  19030
Correspondent Contact DAVID KIM
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received06/10/2016
Decision Date 10/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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