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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, dental
510(k) Number K120283
Device Name DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT
Applicant
NOVOCOL, INC.
416 S Taylor Ave
LOUISVILLE,  CO  80027
Applicant Contact CORA BRACHO-TROSONIS
Correspondent
NOVOCOL, INC.
416 S Taylor Ave
LOUISVILLE,  CO  80027
Correspondent Contact CORA BRACHO-TROSONIS
Regulation Number872.3275
Classification Product Code
EMA  
Date Received01/31/2012
Decision Date 07/31/2012
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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