LoFric Elle

Catheter, Straight

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Lofric Elle.

Pre-market Notification Details

Device IDK211212
510k NumberK211212
Device Name:LoFric Elle
ClassificationCatheter, Straight
Applicant Dentsply Sirona 221 W Philadelphia Street, Suite 60W York,  PA  17401
ContactRebecca Sporer
CorrespondentRebecca Sporer
Dentsply Sirona 221 W Philadelphia Street, Suite 60W York,  PA  17401
Product CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-23
Decision Date2022-02-17

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