CLEARTEMP


Device Classification Name

cement, dental

510(k) Number K111017
Device Name CLEARTEMP
Applicant
ULTRADENT PRODUCTS, INC.
505 west 10200 south
south jordan, 
UT 
84095

Applicant Contact diane rogers
Correspondent
ULTRADENT PRODUCTS, INC.
505 west 10200 south
south jordan, 
UT 
84095

Correspodent Contact diane rogers
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 04/12/2011
Decision Date 06/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No