SmartLite Pro Modular LED Curing Light— 510(k) K191865

Name: FDA 510(k) clearance K191865
Creator: U.S. Food and Drug Administration
Published: 2019-11-20

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K191865 for SmartLite Pro Modular LED Curing Light, Substantially Equivalent on 2019-11-20. Applicant: Dentsply Sirona. Device class: 2.

Clearance details

Applicant: Dentsply Sirona
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2019-07-12
Decision date: 2019-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.