CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE

Material, Tooth Shade, Resin

ALPHA-DENT

The following data is part of a premarket notification filed by Alpha-dent with the FDA for Centrix's Encore Solo Light Activated Resin Core.

Pre-market Notification Details

Device IDK932828
510k NumberK932828
Device Name:CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE
ClassificationMaterial, Tooth Shade, Resin
Applicant ALPHA-DENT 1920 N. CLYBOURN AVE. Chicago,  IL  60614
ContactGeorge Nicolae
CorrespondentGeorge Nicolae
ALPHA-DENT 1920 N. CLYBOURN AVE. Chicago,  IL  60614
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-09
Decision Date1994-02-03

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