DENTITION INTEGRATING MATERIAL

Sealant, Pit And Fissure, And Conditioner

PULPDENT CORPORATION

The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Dentition Integrating Material.

Pre-market Notification Details

Device IDK020287
510k NumberK020287
Device Name:DENTITION INTEGRATING MATERIAL
ClassificationSealant, Pit And Fissure, And Conditioner
Applicant PULPDENT CORPORATION 80 OAKLAND ST. Watertown,  MA  02472
ContactKenneth J Berk
CorrespondentKenneth J Berk
PULPDENT CORPORATION 80 OAKLAND ST. Watertown,  MA  02472
Product CodeEBC  
CFR Regulation Number872.3765 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-28
Decision Date2002-04-12
Summary:summary

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