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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K120619
Device Name ORTHODONTIC FLOWABLE BRACKET ADHESIVE
Applicant
Novocol, Inc.
416 S. Taylor Ave.
Louisville,  CO  80027
Applicant Contact STEVE RUDOLPH
Correspondent
Novocol, Inc.
416 S. Taylor Ave.
Louisville,  CO  80027
Correspondent Contact STEVE RUDOLPH
Regulation Number872.3750
Classification Product Code
DYH  
Date Received02/29/2012
Decision Date 05/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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