ELEMENTS DIAGNOSTIC UNIT


Device Classification Name

tester, pulp

510(k) Number K021298
Device Name ELEMENTS DIAGNOSTIC UNIT
Original Applicant
SYBRON ENDO/ANALYTIC
1717 west collins ave.
orange, 
CA 
92867

Original Contact colleen boswell
Regulation Number 872.1720
Classification Product Code
EAT  
Date Received 04/24/2002
Decision Date 06/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized