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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K120847
Device Name ET/SS IMPLANT 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 Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received03/20/2012
Decision Date 08/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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