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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name material, tooth shade, resin
510(k) Number K141994
Device Name BULK FILL FLOWABLE COMPOSITE
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 Number872.3690
Classification Product Code
EBF  
Date Received07/22/2014
Decision Date 11/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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