14% HYDROFLUORIC ACID ETCHING GEL

Material, Tooth Shade, Resin

PULPDENT CORP.

The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for 14% Hydrofluoric Acid Etching Gel.

Pre-market Notification Details

Device IDK920482
510k NumberK920482
Device Name:14% HYDROFLUORIC ACID ETCHING GEL
ClassificationMaterial, Tooth Shade, Resin
Applicant PULPDENT CORP. 80 OAKLAND ST. P.O. BOX 780 Watertown,  MA  02471 -0780
ContactKenneth J Berk
CorrespondentKenneth J Berk
PULPDENT CORP. 80 OAKLAND ST. P.O. BOX 780 Watertown,  MA  02471 -0780
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-30
Decision Date1992-04-28

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