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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K242521
Device Name Estar-ZE
Applicant
Osstem Implant Co., Ltd.
A-Dong, 51, Mayu-Ro 238beon-Gil
Siheung-Si,  KR 15079
Applicant Contact Seungju Kang
Correspondent
Hiossen, Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Correspondent Contact Peter Lee
Regulation Number872.6660
Classification Product Code
EIH  
Date Received08/23/2024
Decision Date 11/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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