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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, bone
510(k) Number K120951
Device Name SMARTBUILDER SYSTEM
Applicant
OSSTEM IMPLANT CO.,LTD
85 BEN FAIRLESS DR.
FAIRLESS HILLS,  PA  19030
Applicant Contact PATRICK LIM
Correspondent
OSSTEM IMPLANT CO.,LTD
85 BEN FAIRLESS DR.
FAIRLESS HILLS,  PA  19030
Correspondent Contact PATRICK LIM
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
NHA  
Date Received03/30/2012
Decision Date 10/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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