PRELUDE ONE

Agent, Tooth Bonding, Resin

DANVILLE MATERIALS, INC.

The following data is part of a premarket notification filed by Danville Materials, Inc. with the FDA for Prelude One.

Pre-market Notification Details

Device IDK090106
510k NumberK090106
Device Name:PRELUDE ONE
ClassificationAgent, Tooth Bonding, Resin
Applicant DANVILLE MATERIALS, INC. 3420 FOSTORIA WAY, SUITE A-200 San Ramon,  CA  94583
ContactLindsay Tilton
CorrespondentLindsay Tilton
DANVILLE MATERIALS, INC. 3420 FOSTORIA WAY, SUITE A-200 San Ramon,  CA  94583
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-01
Decision Date2009-03-31
Summary:summary

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