SM-EXTRA WIDE (RBM) IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K080128
Device Name SM-EXTRA WIDE (RBM) IMPLANT SYSTEM
Applicant
DIO DEPARTMENT DSI, INC.
3540 wilshire blvd.
suite 1104
los angeles, 
CA 
90010

Applicant Contact hyungick kim
Correspondent
DIO DEPARTMENT DSI, INC.
3540 wilshire blvd.
suite 1104
los angeles, 
CA 
90010

Correspodent Contact hyungick kim
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 01/17/2008
Decision Date 05/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No