FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505


Device Classification Name

varnish, cavity

510(k) Number K080249
Device Name FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505
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 872.3260
Classification Product Code
LBH  
Date Received 01/31/2008
Decision Date 02/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

Yes