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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 K181236
Device Name HySil Impression Materials
Applicant
Osstem Implant Co., Ltd.
203, Geoje-Daero, Yeonje-Gu
Busan,  KR 611-804
Applicant Contact Jungmin Yoo
Correspondent
Hiossen, Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Correspondent Contact David Kim
Regulation Number872.3660
Classification Product Code
ELW  
Date Received05/10/2018
Decision Date 09/13/2018
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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