PERMASHADE VENEER CEMENT


Device Classification Name

cement, dental

510(k) Number K111836
Device Name PERMASHADE VENEER CEMENT
Applicant
ULTRADENT PRODUCTS, INC.
505 west 10200 south
south jordan, 
UT 
84095

Applicant Contact corey jaseph
Correspondent
ULTRADENT PRODUCTS, INC.
505 west 10200 south
south jordan, 
UT 
84095

Correspodent Contact corey jaseph
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 06/29/2011
Decision Date 09/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No