9.6% HYDROFLUORIC ACID GEL

Agent, Tooth Bonding, Resin

PULPDENT CORP.

The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for 9.6% Hydrofluoric Acid Gel.

Pre-market Notification Details

Device IDK896655
510k NumberK896655
Device Name:9.6% HYDROFLUORIC ACID GEL
ClassificationAgent, Tooth Bonding, 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 CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-24
Decision Date1990-02-14

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