DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT

Cement, Dental

NOVOCOL, INC.

The following data is part of a premarket notification filed by Novocol, Inc. with the FDA for Dimer Dual Cure Permanent/temporary Resin Cement.

Pre-market Notification Details

Device IDK120283
510k NumberK120283
Device Name:DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT
ClassificationCement, Dental
Applicant NOVOCOL, INC. 416 S Taylor Ave Louisville,  CO  80027
ContactCora Bracho-trosonis
CorrespondentCora Bracho-trosonis
NOVOCOL, INC. 416 S Taylor Ave Louisville,  CO  80027
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-31
Decision Date2012-07-31

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