HG II FIXTURE SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K080744
Device Name HG II FIXTURE SYSTEM
Applicant
OSSTEM IMPLANT CO.,LTD
one ben fairless dr.
fairless hills, 
PA 
19030

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

Correspodent Contact minjoo kim
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 03/17/2008
Decision Date 07/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No