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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 K163088
Device Name TSIII BA Fixture
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  
Date Received11/04/2016
Decision Date 04/21/2017
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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