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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 K130601
Device Name BIOROOT RCS
Applicant
NOVOCOL, INC.
416 SOUTH TAYLOR AVE.
LOUISVILLE,  CO  80027
Applicant Contact CORA BRACHO-TROCONIS
Correspondent
NOVOCOL, INC.
416 SOUTH TAYLOR AVE.
LOUISVILLE,  CO  80027
Correspondent Contact CORA BRACHO-TROCONIS
Regulation Number872.3820
Classification Product Code
KIF  
Date Received03/07/2013
Decision Date 10/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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