TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT


Device Classification Name

adhesive, bracket and tooth conditioner, resin

510(k) Number K030036
Device Name TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT
Original Applicant
PULPDENT CORPORATION
80 oakland st.
watertown, 
MA 
02472

Original Contact kenneth j berk
Regulation Number 872.3750
Classification Product Code
DYH  
Subsequent Product Code
EMA  
Date Received 01/03/2003
Decision Date 03/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No