DRYING AGENT

Material, Tooth Shade, Resin

PULPDENT CORP.

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

Pre-market Notification Details

Device IDK896654
510k NumberK896654
Device Name:DRYING AGENT
ClassificationMaterial, Tooth Shade, Resin
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 CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-24
Decision Date1990-02-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D701SDRY12 K896654 000

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