PROSTHETIC SYSTEM


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K110308
Device Name PROSTHETIC 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 02/02/2011
Decision Date 10/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No