SmartLite Pro Modular LED Curing Light

Activator, Ultraviolet, For Polymerization

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Smartlite Pro Modular Led Curing Light.

Pre-market Notification Details

Device IDK191865
501k NumberK191865
Device Name:SmartLite Pro Modular LED Curing Light
ClassificationActivator, Ultraviolet, For Polymerization
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 CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-12
Decision Date2019-11-20

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