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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 a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2019-11-20 under approval 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. It is manufactured by Dentsply Sirona. The 510(k) number is K191865.

When was SmartLite Pro Modular LED Curing Light approved by the FDA?

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

What company makes SmartLite Pro Modular LED Curing Light?

SmartLite Pro Modular LED Curing Light is manufactured by Dentsply Sirona.

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)

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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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