KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI

Material, Tooth Shade, Resin

KERR CORPORATION (DANBURY)

The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Kerr Herculite Dental Composite Restorative Materi.

Pre-market Notification Details

Device IDK844662
510k NumberK844662
Device Name:KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI
ClassificationMaterial, Tooth Shade, Resin
Applicant KERR CORPORATION (DANBURY) SUITE 1200 Washington,  DC  20005
ContactStephen Kurzman
CorrespondentStephen Kurzman
KERR CORPORATION (DANBURY) SUITE 1200 Washington,  DC  20005
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-11-30
Decision Date1985-03-25

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