PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT

Cement, Dental

PRIME DENTAL MANUFACTURING, INC.

The following data is part of a premarket notification filed by Prime Dental Manufacturing, Inc. with the FDA for Prime-dent Dual Cure Composite Luting Cement.

Pre-market Notification Details

Device IDK112574
510k NumberK112574
Device Name:PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT
ClassificationCement, Dental
Applicant PRIME DENTAL MANUFACTURING, INC. 4555 WEST ADDISON STREET Chicago,  IL  60641
ContactJavier Alvarez
CorrespondentJavier Alvarez
PRIME DENTAL MANUFACTURING, INC. 4555 WEST ADDISON STREET Chicago,  IL  60641
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-06
Decision Date2012-01-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810152820070 K112574 000

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