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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 K053167
Device Name BIOPURE MTAD ROOT CANAL CLEANSER
Applicant
Dentsply Intl., Inc.
Susquehanna Commerce Center
221 W. Philadelphia St., Suite 60
York,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
Dentsply Intl., Inc.
Susquehanna Commerce Center
221 W. Philadelphia St., Suite 60
York,  PA  17404
Correspondent Contact HELEN LEWIS
Classification Product Code
KJJ  
Date Received11/14/2005
Decision Date 12/08/2005
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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