FDA 510(k)

LED Curing Light

K-Number: K161855 · 2017-11-27

Decision Date2017-11-27

Product CodeEBZ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

LED Curing Light is a medical device manufactured by Monitex Industrial Co., Ltd.. It received FDA 510(k) clearance on 2017-11-27 under approval number K161855. 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 LED Curing Light?

LED Curing Light is a medical device that received FDA 510(k) clearance on 2017-11-27. It is manufactured by Monitex Industrial Co., Ltd.. The 510(k) number is K161855.

When was LED Curing Light approved by the FDA?

LED Curing Light received FDA 510(k) clearance on 2017-11-27, under approval number K161855.

What company makes LED Curing Light?

LED Curing Light is manufactured by Monitex Industrial Co., Ltd..

What is the FDA product code for LED Curing Light?

The FDA product code for LED Curing Light is EBZ.

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Other Devices by Monitex Industrial Co., Ltd.

K153078LED Curing Light GT-2000 K152192LED Curing Light

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 K172426Clear Blue Digi LED Curing LightPromident, LLC K170529Delight, Delight ortho, B&Lite SDentall Co., Ltd.

Official Source

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