DURAGARD SODIUM FLUORIDE VARNISH


information about

Device Classification Name

varnish, cavity

510(k) Number K002581
Device Name DURAGARD SODIUM FLUORIDE VARNISH
Original Applicant
SULTAN DENTAL PRODUCTS, LTD.
242 south dean st.
englewood, 
NJ 
07631

Original Contact george wolfe
Regulation Number 872.3260
Classification Product Code
LBH  
Date Received 08/18/2000
Decision Date 10/20/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No