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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 K130662
Device Name ET PROSTHETIC SYSTEM
Applicant
Osstem Implant Co., Ltd.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Applicant Contact PATRICK LIM
Correspondent
Osstem Implant Co., Ltd.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Correspondent Contact PATRICK LIM
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/12/2013
Decision Date 01/10/2014
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
Recalls CDRH Recalls
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