Navina Smart System, Navina Classic System

Tubes, Gastrointestinal (and Accessories)

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Navina Smart System, Navina Classic System.

Pre-market Notification Details

Device IDK190977
501k NumberK190977
Device Name:Navina Smart System, Navina Classic System
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant Dentsply Sirona 221 West Philadelphia Street, Suite 60W York,  PA  17401
ContactKarl Nittinger
CorrespondentKarl Nittinger
Dentsply Sirona 221 West Philadelphia Street, Suite 60W York,  PA  17401
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-15
Decision Date2019-11-22

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