RMGI LOW VISCOSITY

Cement, Dental

PULPDENT CORPORATION

The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Rmgi Low Viscosity.

Pre-market Notification Details

Device IDK123265
510k NumberK123265
Device Name:RMGI LOW VISCOSITY
ClassificationCement, Dental
Applicant PULPDENT CORPORATION 80 Oakland St Watertown,  MA  02472
ContactKenneth J Berk
CorrespondentKenneth J Berk
PULPDENT CORPORATION 80 Oakland St Watertown,  MA  02472
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-19
Decision Date2012-12-07
Summary:summary

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