DIO BIOTITE-H IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K073070
Device Name DIO BIOTITE-H IMPLANT SYSTEM
Applicant
DIO DEPARTMENT DSI, INC.
13340 e. firestone blvd
suite j
santa fe springs, 
CA 
90670

Applicant Contact steve chang
Correspondent
DIO DEPARTMENT DSI, INC.
13340 e. firestone blvd
suite j
santa fe springs, 
CA 
90670

Correspodent Contact steve chang
Regulation Number 872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received 10/30/2007
Decision Date 05/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No