NO-STICK COMPOSITE INSTRUMENT DIP

Coating, Filling Material, Resin

PULPDENT CORP.

The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for No-stick Composite Instrument Dip.

Pre-market Notification Details

Device IDK901050
510k NumberK901050
Device Name:NO-STICK COMPOSITE INSTRUMENT DIP
ClassificationCoating, Filling Material, 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 CodeEBD  
CFR Regulation Number872.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-05
Decision Date1990-04-19

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