PULPDENT CAVITY PREPARATION III

Varnish, Cavity

PULPDENT CORP.

The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for Pulpdent Cavity Preparation Iii.

Pre-market Notification Details

Device IDK994180
510k NumberK994180
Device Name:PULPDENT CAVITY PREPARATION III
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 Received1999-12-10
Decision Date2000-03-02

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