PULPDENT CALCIUM HYDROXIDE PREPARATION


Device Classification Name

resin, root canal filling

510(k) Number K022734
Device Name PULPDENT CALCIUM HYDROXIDE PREPARATION
Original Applicant
PULPDENT CORPORATION
80 oakland st.
watertown, 
MA 
02472

Original Contact kenneth j berk
Regulation Number 872.3820
Classification Product Code
KIF  
Date Received 08/16/2002
Decision Date 10/07/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No