FDA 510(k)

LED Curing Light GT-2000

K-Number: K153078 · 2016-06-28

Decision Date2016-06-28

Product CodeEBZ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

LED Curing Light GT-2000 is a medical device manufactured by Monitex Industrial Co., Ltd.. It received FDA 510(k) clearance on 2016-06-28 under approval number K153078. 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 GT-2000?

LED Curing Light GT-2000 is a medical device that received FDA 510(k) clearance on 2016-06-28. It is manufactured by Monitex Industrial Co., Ltd.. The 510(k) number is K153078.

When was LED Curing Light GT-2000 approved by the FDA?

LED Curing Light GT-2000 received FDA 510(k) clearance on 2016-06-28, under approval number K153078.

What company makes LED Curing Light GT-2000?

LED Curing Light GT-2000 is manufactured by Monitex Industrial Co., Ltd..

What is the FDA product code for LED Curing Light GT-2000?

The FDA product code for LED Curing Light GT-2000 is EBZ.

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Other Devices by Monitex Industrial Co., Ltd.

K161855LED Curing Light K152192LED Curing Light

Related Devices (Code: EBZ)

K153514Premium Plus C01/C02 LED Curing LightPremium Plus International Limited K160551VALO GrandUltradent Products, Inc. K153018CELALUX 3Voco GmbH K161855LED Curing LightMonitex Industrial Co., Ltd. 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.