DENTIN DESENSITIZER AGENT

Varnish, Cavity

DENTSPLY INTL., INC.

The following data is part of a premarket notification filed by Dentsply Intl., Inc. with the FDA for Dentin Desensitizer Agent.

Pre-market Notification Details

Device IDK073117
510k NumberK073117
Device Name:DENTIN DESENSITIZER AGENT
ClassificationVarnish, Cavity
Applicant DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER 221 W PHILADELPHIA ST. STE 60 York,  PA  17404
ContactHelen Lewis
CorrespondentHelen Lewis
DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER 221 W PHILADELPHIA ST. STE 60 York,  PA  17404
Product CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-05
Decision Date2007-12-19
Summary:summary

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