Bonart ART-L5 LED Cordless Curing Light
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K082971 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 Bonart Art-L5 LED Cordless Curing Light is a dental device designed for polymerization of dental materials. It features an ergonomically designed gun-shaped handle and operates with three curing modes: Fast, Ramp, and Pulse. The device has an optical wavelength and delivers light intensity up to 1400mW/cm² through a 7.0mm/70 degree light guide.
This cordless curing light is supplied as a complete system and automatically switches to sleep mode when idle to conserve energy. It is intended for dental use and is regulated under FDA 510K clearance with product code EBZ. The device is Class II and has received clearance from the Dental advisory committee.
Frequently asked questions
What is the BONART ART-L5 LED Cordless Curing Light used for?
The BONART ART-L5 is a dental device designed specifically for polymerization of dental materials. It features an ergonomically designed gun-shaped handle and operates with three curing modes: Fast, Ramp, and Pulse, making it suitable for various dental procedures requiring light curing.
How is the BONART ART-L5 LED Cordless Curing Light supplied?
The device is supplied as a complete system. It is cordless for convenience and automatically switches to sleep mode when idle to conserve energy. This feature helps prolong battery life and ensures the device is ready for use when needed.
What are the specifications of the BONART ART-L5 LED Cordless Curing Light?
The BONART ART-L5 delivers light intensity up to 1400mW/cm² through a 7.0mm/70 degree light guide. It has an optical wavelength suitable for dental material polymerization. The device is Class II and has received FDA 510K clearance with product code EBZ.
Is the BONART ART-L5 LED Cordless Curing Light reusable or single-use?
The BONART ART-L5 is a reusable device designed for multiple dental procedures. It is constructed as a durable cordless system with an ergonomic handle and automatic sleep mode functionality, indicating it is intended for repeated use in clinical settings rather than being disposable.
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: Dental curing light - ART-L5 - Bonart - cordless / LED - MedicalExpo, BONART ART-L5 DIRECTIONS FOR USE MANUAL Pdf Download, Bonart ART-L5 Manuals | ManualsLib, Curing Light Cordless LED L5 (BonArt) - pricenex.com, LED curing light / dental / cordless ART-L5 Bonart Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082971 | Class II | Active |
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Manufacturer
- Manufacturer
- Bonart Co., Ltd.
Sources (1)
- FDA 510(k) K082971 24 fields · synced Sep 26, 2026