HU II / HS II FIXTURE SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K080387
Device Name HU II / HS II FIXTURE SYSTEM
Applicant
OSSTEM IMPLANT CO.,LTD
1 ben fairless dr.
fairless, 
PA 
19030

Applicant Contact min joo kim
Correspondent
OSSTEM IMPLANT CO.,LTD
1 ben fairless dr.
fairless, 
PA 
19030

Correspodent Contact min joo kim
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 02/13/2008
Decision Date 03/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No