ULTRASEAL XT HYDRO


Device Classification Name

sealant, pit and fissure, and conditioner

510(k) Number K112517
Device Name ULTRASEAL XT HYDRO
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 872.3765
Classification Product Code
EBC  
Date Received 08/31/2011
Decision Date 09/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No