GS FIXTURE SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K072896
Device Name GS FIXTURE SYSTEM
Applicant
OSSTEM IMPLANT CO.,LTD
one ben fairless dr.
fairless hills, 
PA 
19030

Applicant Contact kim m joo
Correspondent
OSSTEM IMPLANT CO.,LTD
one ben fairless dr.
fairless hills, 
PA 
19030

Correspodent Contact kim m joo
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 10/11/2007
Decision Date 11/06/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No