PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS

Varnish, Cavity

PULPDENT CORP.

The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for Pulpdent Cavity Cleanser, Pulpdent Cavity Cleanser Plus.

Pre-market Notification Details

Device IDK974202
510k NumberK974202
Device Name:PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS
ClassificationVarnish, Cavity
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 CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-10
Decision Date1998-03-19
Summary:summary

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