MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT


Device Classification Name

liner, cavity, calcium hydroxide

510(k) Number K022025
Device Name MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
Original Applicant
MILTON HODOSH, M.D.
243 elwood ave.
providence, 
RI 
02907

Original Contact milton hodosh
Regulation Number 872.3250
Classification Product Code
EJK  
Date Received 06/20/2002
Decision Date 08/15/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No