SEAL RITE PROCEDURE KIT(TM)

Sealant, Pit And Fissure, And Conditioner

PULPDENT CORP.

The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for Seal Rite Procedure Kit(tm).

Pre-market Notification Details

Device IDK902023
510k NumberK902023
Device Name:SEAL RITE PROCEDURE KIT(TM)
ClassificationSealant, Pit And Fissure, And Conditioner
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 CodeEBC  
CFR Regulation Number872.3765 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-04
Decision Date1990-07-13

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