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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(K) Number K121843
Device Name NP-CAST ABUTMENT SYSTEM
Applicant
OSSTEM IMPLANT CO.,LTD
85 ben fairless dr
fairless hills,  PA  19030
Contact patrick lim
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/25/2012
Decision Date 12/11/2012
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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