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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K011009
Device Name WHITE MTA MATERIAL
Applicant
Dentsply International
570 W. College Ave.
York,  PA  17404
Applicant Contact P.JEFFERY LEHN
Correspondent
Dentsply International
570 W. College Ave.
York,  PA  17404
Correspondent Contact P.JEFFERY LEHN
Regulation Number872.3820
Classification Product Code
KIF  
Date Received04/04/2001
Decision Date 05/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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