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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, Orthodontic
510(k) Number K103105
Device Name ORTHODONTIC SCREW
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
OAT  
Date Received10/20/2010
Decision Date 03/25/2011
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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