NP-CAST ABUTMENT SYSTEM


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 Number 872.3630
Classification Product Code
NHA  
Date Received 06/25/2012
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