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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 K192941
Device Name HySil Super Fast Impression Materials
Applicant
Osstem Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu
Busan,  KR 48002
Applicant Contact Jungmin Yoo
Correspondent
Hiossen Inc.
85 Ben Fairless Dr.
Fairless Hills,  PA  19030
Correspondent Contact Peter Lee
Regulation Number872.3660
Classification Product Code
ELW  
Date Received10/18/2019
Decision Date 01/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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