ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)


Device Classification Name

crown and bridge, temporary, resin

510(k) Number K103474
Device Name ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
Applicant
MICERIUM S.P.A.
via marconi 83
avengo, 

IT

16030

Applicant Contact ssa carla tazzer
Correspondent
MICERIUM S.P.A.
via marconi 83
avengo, 

IT

16030

Correspodent Contact ssa carla tazzer
Regulation Number 872.3770
Classification Product Code
EBG  
Date Received 11/26/2010
Decision Date 02/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No