PULPDENT CALCIUM HYDROXIDE PREPARATIONS

Liner, Cavity, Calcium Hydroxide

PULPDENT CORP.

The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for Pulpdent Calcium Hydroxide Preparations.

Pre-market Notification Details

Device IDK944945
510k NumberK944945
Device Name:PULPDENT CALCIUM HYDROXIDE PREPARATIONS
ClassificationLiner, Cavity, Calcium Hydroxide
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 CodeEJK  
CFR Regulation Number872.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-07
Decision Date1994-11-30

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