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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name agent, polishing, abrasive, oral cavity
510(k) Number K000169
Device Name NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
Applicant
DENTSPLY INTL.
570 WEST COLLEGE AVE.
YORK,  PA  17405 -0872
Applicant Contact P. JEFFERY LEHN
Correspondent
DENTSPLY INTL.
570 WEST COLLEGE AVE.
YORK,  PA  17405 -0872
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.6030
Classification Product Code
EJR  
Date Received01/20/2000
Decision Date 03/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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