DELTON ILLUMINATING PIT AND FISSURE SEALING

Sealant, Pit And Fissure, And Conditioner

DENTSPLY INTERNATIONAL

The following data is part of a premarket notification filed by Dentsply International with the FDA for Delton Illuminating Pit And Fissure Sealing.

Pre-market Notification Details

Device IDK050959
510k NumberK050959
Device Name:DELTON ILLUMINATING PIT AND FISSURE SEALING
ClassificationSealant, Pit And Fissure, And Conditioner
Applicant DENTSPLY INTERNATIONAL 221 W. PHILADELPHIA ST. SUITE 60 York,  PA  17404
ContactHelen Lewis
CorrespondentHelen Lewis
DENTSPLY INTERNATIONAL 221 W. PHILADELPHIA ST. SUITE 60 York,  PA  17404
Product CodeEBC  
CFR Regulation Number872.3765 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-18
Decision Date2005-05-11
Summary:summary

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