PULPDENT RESILUTE II

Cement, Dental

PULPDENT CORP.

The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for Pulpdent Resilute Ii.

Pre-market Notification Details

Device IDK962383
510k NumberK962383
Device Name:PULPDENT RESILUTE II
ClassificationCement, Dental
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 CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-20
Decision Date1996-09-03
Summary:summary

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