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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 K121995
Device Name TS FIXTURE SYSTEM
Original Applicant
OSSTEM IMPLANT CO.,LTD
85 ben fairless dr.
fairless hills,  PA  19030
Original Contact patrick lim
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/09/2012
Decision Date 11/29/2012
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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