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LED Curing Light, Model GT-1500

FDA 510(k)

Class II (US FDA 510(k))

510(k) K091887

by Monitex Industrial Co., Ltd.

Identifiers

510(k) Number
K091887 FDA 510(k)
FDA Product Code
EBZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.6070 FDA 510(k)
Regulation Number
872.6070 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

An LED curing light is a device used for the polymerization of light-cure materials in dental applications. The LED Curing Light, Model GT-1500 is a cordless device designed to deliver light intensity for the curing of dental composites and resin restorations.

It is supplied as a reusable device intended for use in dental clinical settings. The device is classified as FDA Class II under product code EBZ and regulation number 872.6070, with authorization via FDA 510(k) clearance K091887. Sterility, MRI safety, and specific storage conditions are not stated in the provided data.

Frequently asked questions

What is the LED Curing Light, Model GT-1500 used for?

The LED Curing Light, Model GT-1500 is used for the polymerization of light-cure materials in dental applications, specifically to cure dental composites and resin restorations by delivering light intensity for clinical use.

How is the LED Curing Light, Model GT-1500 supplied and is it reusable?

The device is supplied as a reusable unit intended for use in dental clinical settings, meaning it is designed for multiple uses after appropriate cleaning and maintenance between patients.

What regulatory pathway was used for the LED Curing Light, Model GT-1500?

The LED Curing Light, Model GT-1500 received authorization via FDA 510(k) clearance under submission number K091887, indicating it was found substantially equivalent to a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Monitex Industrial Co. - Monitex Industrial Co., Ti-Lite GT-1500 - Monitex Industrial Co., LED CURING LIGHT, MODEL GT-1500 (K091887) — FDA 510 (k) | Innolitics, MONITEX TI-LITE GT-1500 USER MANUAL Pdf Download, Monitex Ti-Lite GT-1500 Manuals | ManualsLib

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Monitex Industrial Co., Ltd.

Sources (1)

  • FDA 510(k) K091887 24 fields · synced Sep 22, 2026