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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cleanser, root canal
510(k) Number K032361
Device Name ENDOPURE ROOT CANAL CLEANSER
Applicant
DENTSPLY INTL.
570 WEST COLLEGE AVENUE
P.O. BOX 872
YORK,  PA  17405 -0872
Applicant Contact P. JEFFERY LEHN
Correspondent
DENTSPLY INTL.
570 WEST COLLEGE AVENUE
P.O. BOX 872
YORK,  PA  17405 -0872
Correspondent Contact P. JEFFERY LEHN
Classification Product Code
KJJ  
Date Received07/31/2003
Decision Date 01/12/2004
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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