PULPDENT SEMI-GEL ETCH


Device Classification Name

material, tooth shade, resin

510(k) Number K022492
Device Name PULPDENT SEMI-GEL ETCH
Original Applicant
PULPDENT CORPORATION
80 oakland st.
watertown, 
MA 
02472

Original Contact kenneth j berk
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 07/29/2002
Decision Date 10/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No