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FDA 510(k)

Coltolux Comfort LED Curing Light

K-Number: K223142 · 2022-12-22

ApplicantDent4you AG
Decision Date2022-12-22
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Coltolux Comfort LED Curing Light is a medical device manufactured by Dent4you AG. It received FDA 510(k) clearance on 2022-12-22 under approval number K223142. 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 Coltolux Comfort LED Curing Light?

Coltolux Comfort LED Curing Light is a medical device that received FDA 510(k) clearance on 2022-12-22. It is manufactured by Dent4you AG. The 510(k) number is K223142.

When was Coltolux Comfort LED Curing Light approved by the FDA?

Coltolux Comfort LED Curing Light received FDA 510(k) clearance on 2022-12-22, under approval number K223142.

What company makes Coltolux Comfort LED Curing Light?

Coltolux Comfort LED Curing Light is manufactured by Dent4you AG.

What is the FDA product code for Coltolux Comfort LED Curing Light?

The FDA product code for Coltolux Comfort LED Curing Light is EBZ.

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Other Devices by Dent4you AG

K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator K240801BioSonic US200 Ultrasonic Scaler (60034537) K250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST

Related Devices (Code: EBZ)

K153514Premium Plus C01/C02 LED Curing LightPremium Plus International Limited K160551VALO GrandUltradent Products, Inc. K153078LED Curing Light GT-2000Monitex Industrial Co., Ltd. K153018CELALUX 3Voco GmbH K161855LED Curing LightMonitex Industrial Co., Ltd. K172426Clear Blue Digi LED Curing LightPromident, 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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