KEN'S PROPHY GEL - REGULAR

Agent, Polishing, Abrasive, Oral Cavity

PULPDENT CORP.

The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for Ken's Prophy Gel - Regular.

Pre-market Notification Details

Device IDK896661
510k NumberK896661
Device Name:KEN'S PROPHY GEL - REGULAR
ClassificationAgent, Polishing, Abrasive, Oral Cavity
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 CodeEJR  
CFR Regulation Number872.6030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-24
Decision Date1990-02-14

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