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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K110484
Device Name SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
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 Number872.3770
Classification Product Code
EBG  
Date Received02/18/2011
Decision Date 05/17/2011
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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