US/GS ULTRA WIDE SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K073465
Device Name US/GS ULTRA WIDE SYSTEM
Applicant
OSSTEM IMPLANT CO.,LTD
one ben fairless dr.
fairless hills, 
PA 
19030

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

Correspodent Contact min joo kim
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 12/10/2007
Decision Date 04/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No