RMGI FILL

Cement, Dental

PULPDENT CORPORATION

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

Pre-market Notification Details

Device IDK130223
510k NumberK130223
Device Name:RMGI FILL
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 Received2013-01-29
Decision Date2013-03-29
Summary:summary

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