ULTRATEMP FIRM, FAST AND REGULAR SET


Device Classification Name

cement, dental

510(k) Number K080768
Device Name ULTRATEMP FIRM, FAST AND REGULAR SET
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 03/18/2008
Decision Date 04/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No