Identifiers
- 510(k) Number
- K153078 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)
The LED Curing Light GT-2000 is a dental device that uses blue and UV spectrum LEDs to cure dental composites. It operates with a wavelength range between 360~490 nm and can polymerize most composite materials within 10 seconds.
This device is manufactured by Monitex Industrial Co., Ltd. and is supplied as a Class 2 dental device with product code EBZ. It received FDA 510(k) clearance through the Traditional pathway after a 249-day review.
Frequently asked questions
What is the LED Curing Light GT-2000 used for?
The LED Curing Light GT-2000 is a dental device that uses blue and UV spectrum LEDs to cure dental composites. It can polymerize most composite materials within 10 seconds, making it efficient for dental procedures.
How is the LED Curing Light GT-2000 supplied?
The device is supplied as a Class 2 dental device with product code EBZ. It is manufactured by Monitex Industrial Co., Ltd. and received FDA 510(k) clearance through the Traditional pathway after a 249-day review.
What are the specifications of the LED Curing Light GT-2000?
The LED Curing Light GT-2000 operates with a wavelength range between 360~490 nm. It is designed to polymerize most dental composite materials efficiently within 10 seconds, providing reliable curing performance for dental applications.
Is the LED Curing Light GT-2000 reusable or single-use?
The device is designed for reuse as it is a dental curing light intended for multiple clinical applications. It is supplied as a Class 2 dental device, which typically indicates reusable equipment that requires proper cleaning and maintenance between uses.
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: TwinWave GT-2000 - Monitex Industrial Co., Monitex Industrial Co. - Monitex Industrial Co., K153078 FDA 510 (k) - LED Curing Light GT-2000, LED Curing Light GT-2000 (K153078) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153078 | Class II | Active |
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Manufacturer
- Manufacturer
- Monitex Industrial Co., Ltd.
Sources (1)
- FDA 510(k) K153078 24 fields · synced Sep 26, 2026