INFILTRATION KIT


Device Classification Name

sealant, pit and fissure, and conditioner

510(k) Number K081493
Device Name INFILTRATION KIT
Applicant
DMG USA, INC.
5 whitcomb ave.
ayer, 
MA 
01432

Applicant Contact pamela papineau
Correspondent
DMG USA, INC.
5 whitcomb ave.
ayer, 
MA 
01432

Correspodent Contact pamela papineau
Regulation Number 872.3765
Classification Product Code
EBC  
Date Received 05/28/2008
Decision Date 09/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No