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FDA 510(k)

SmartLite Pro Modular LED Curing Light

K-Number: K191865 · 2019-11-20

ApplicantDentsply Sirona
Decision Date2019-11-20
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SmartLite Pro Modular LED Curing Light is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2019-11-20 under 510(k) number K191865. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartLite Pro Modular LED Curing Light?

SmartLite Pro Modular LED Curing Light is a medical device that received FDA 510(k) clearance on 2019-11-20. The listed applicant is Dentsply Sirona. The 510(k) number is K191865.

When did SmartLite Pro Modular LED Curing Light receive FDA 510(k) clearance?

SmartLite Pro Modular LED Curing Light received FDA 510(k) clearance on 2019-11-20, under 510(k) number K191865.

Who is the listed applicant for SmartLite Pro Modular LED Curing Light?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartLite Pro Modular LED Curing Light?

The FDA product code for SmartLite Pro Modular LED Curing Light is EBZ.

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Related Devices (Code: EBZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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