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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 K233194
Device Name TS Abutment System
Osstem Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu
Busan,  KR 48002
Applicant Contact Seungju Kang
HioSSEN Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Correspondent Contact Peter Lee
Regulation Number872.3630
Classification Product Code
Date Received09/28/2023
Decision Date 02/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No