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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 K121585
Device Name TS IMPLANT SYSTEM
Applicant
OSSTEM IMPLANT CO.,LTD
85 ben fairless dr.
fairless hills,  PA  19030
Contact patrick lim
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/31/2012
Decision Date 01/07/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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