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FDA 510(k)

LED Curing Light GT-2000

K-Number: K153078 · 2016-06-28

ApplicantMonitex Industrial Co., Ltd.
Decision Date2016-06-28
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LED Curing Light GT-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Monitex Industrial Co., Ltd.. It received FDA 510(k) clearance on 2016-06-28 under 510(k) 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. The listed applicant is Monitex Industrial Co., Ltd.. The 510(k) number is K153078.

When did LED Curing Light GT-2000 receive FDA 510(k) clearance?

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

Who is the listed applicant for LED Curing Light GT-2000?

The FDA 510(k) record lists Monitex Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Monitex Industrial Co., Ltd. as applicant

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.

K161855LED Curing LightK152192LED Curing Light

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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