PULPDENT DENTASTIC UNO

Cement, Dental

PULPDENT CORP.

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

Pre-market Notification Details

Device IDK974014
510k NumberK974014
Device Name:PULPDENT DENTASTIC UNO
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 Received1997-10-22
Decision Date1997-12-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D7796541020 K974014 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.