SIMPACT IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K081226
Device Name SIMPACT IMPLANT SYSTEM
Applicant
SIMPACT LLC
300 interpace parkway
building c 3rd floor
parsippany, 
NJ 
07054

Applicant Contact alan lombardo
Correspondent
SIMPACT LLC
300 interpace parkway
building c 3rd floor
parsippany, 
NJ 
07054

Correspodent Contact alan lombardo
Regulation Number 872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received 04/30/2008
Decision Date 09/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No