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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 K080203
Device Name MTA ROOT CANAL SEALER
Applicant
Dentsply Interntional
221 W. Philadelphia St. Suite 60
Susquehanna Commerce Crt. W.
York,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
Dentsply Interntional
221 W. Philadelphia St. Suite 60
Susquehanna Commerce Crt. W.
York,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.3820
Classification Product Code
KIF  
Date Received01/28/2008
Decision Date 03/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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