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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 K083062
Device Name ROOT CANAL XR
Applicant
S & C Polymer GmbH
Robert-Bosch-Strasse 5
Elmshorn,  DE D-25335
Applicant Contact CHRISTIAN BOETTCHER
Correspondent
S & C Polymer GmbH
Robert-Bosch-Strasse 5
Elmshorn,  DE D-25335
Correspondent Contact CHRISTIAN BOETTCHER
Regulation Number872.3820
Classification Product Code
KIF  
Date Received10/14/2008
Decision Date 03/12/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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