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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 K120237
Device Name BPA-FREE MICROHYBID COMPOSITE
Applicant
NOVOCOL, INC.
416 S Taylor Ave
LOUISVILLE,  CO  80027
Applicant Contact CORA BRACHO-TROCONIS
Correspondent
NOVOCOL, INC.
416 S Taylor Ave
LOUISVILLE,  CO  80027
Correspondent Contact CORA BRACHO-TROCONIS
Regulation Number872.3690
Classification Product Code
EBF  
Date Received01/26/2012
Decision Date 12/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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