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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K212303
Device Name T2
Applicant
Osstem Implant Co., Ltd.
2 Floor, B-Dong, 51, Mayu-Ro 238beon-Gil
Siheung-Si,  KR 15079
Applicant Contact Jinwoo Bae
Correspondent
Hiossen, Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Correspondent Contact Peter Lee
Regulation Number892.1750
Classification Product Code
OAS  
Date Received07/23/2021
Decision Date 09/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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