TS IMPLANT SYSTEM


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

Applicant Contact patrick lim
Correspondent
OSSTEM IMPLANT CO.,LTD
85 ben fairless dr.
fairless hills, 
PA 
19030

Correspodent Contact patrick lim
Regulation Number 872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received 05/31/2012
Decision Date 01/07/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No