PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL

Material, Tooth Shade, Resin

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 Chemical Cure Composite Restorative Material.

Pre-market Notification Details

Device IDK994224
510k NumberK994224
Device Name:PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL
ClassificationMaterial, Tooth Shade, Resin
Applicant PRIME DENTAL MANUFACTURING, INC. 3735 WEST BELMONT AVE. Chicago,  IL  60618
ContactRolando Marasigan
CorrespondentRolando Marasigan
PRIME DENTAL MANUFACTURING, INC. 3735 WEST BELMONT AVE. Chicago,  IL  60618
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-15
Decision Date2000-01-31

NIH GUDID Devices

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