PULPDENT SEMI-GEL ETCH

Material, Tooth Shade, Resin

PULPDENT CORPORATION

The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Pulpdent Semi-gel Etch.

Pre-market Notification Details

Device IDK022492
510k NumberK022492
Device Name:PULPDENT SEMI-GEL ETCH
ClassificationMaterial, Tooth Shade, Resin
Applicant PULPDENT CORPORATION 80 OAKLAND ST. Watertown,  MA  02472
ContactKenneth J Berk
CorrespondentKenneth J Berk
PULPDENT CORPORATION 80 OAKLAND ST. Watertown,  MA  02472
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-29
Decision Date2002-10-11
Summary:summary

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