TEMPOCEM


Device Classification Name

zinc oxide eugenol

510(k) Number K110759
Device Name TEMPOCEM
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 872.3275
Classification Product Code
EMB  
Date Received 03/18/2011
Decision Date 06/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No