D/SENSE 1-STEP


Device Classification Name

liner, cavity, calcium hydroxide

510(k) Number K021146
Device Name D/SENSE 1-STEP
Original Applicant
CENTRIX, INC.
770 river rd.
shelton, 
CT 
06484 -5458

Original Contact john discko
Regulation Number 872.3250
Classification Product Code
EJK  
Date Received 04/09/2002
Decision Date 07/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No