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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K151262
Device Name Hyflex Heavy, Hyflex Mono, Hyflex Light
Applicant
Osstem Implant Co., Ltd.
66-16, Bansong-Ro 513beon-Gil, Haeundae-Gu
Busan,  KR 612-070
Applicant Contact Heekwon Son
Correspondent
Hiossen, Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Correspondent Contact Patrick Lim
Regulation Number872.3660
Classification Product Code
ELW  
Date Received05/13/2015
Decision Date 09/21/2015
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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