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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
Applicant Contact patrick lim
Correspondent
OSSTEM IMPLANT CO.,LTD
85 ben fairless dr
fairless hills,  PA  19030
Correspodent Contact patrick lim
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/25/2012
Decision Date 12/11/2012
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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