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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K152830
Device Name K3
Applicant
Osstem Implant Co., Ltd.
1st Floor, B-Dong, 135 Gasan Digital 2-Ro, Geumcheon-Gu
Seoul,  KR 153-759
Applicant Contact BYEUNGHUN KIM
Correspondent
Hiossen, Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Correspondent Contact David Kim
Regulation Number872.6640
Classification Product Code
EIA  
Date Received09/29/2015
Decision Date 04/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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