Identifiers
- 510(k) Number
- K130163 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 D-Lux Cordless Ultraviolet Activator is a Class II dental device designed for polymerizing light-cured dental materials. It functions as an ultraviolet curing light, delivering controlled light energy to initiate and complete the polymerization process in composite resins, adhesives, and other photopolymerizable substances used in restorative and aesthetic dental procedures.
This device is supplied as a cordless, reusable unit with a heat-dissipating aluminum construction to ensure consistent performance and safety. It operates in dental clinics and offices, adhering to regulatory standards including FDA 510K clearance under the Medical Device Regulation (MDR) and the classification of Activator, Ultraviolet, For Polymerization. The device is not single-use and requires proper storage to maintain functionality, with no specific MRI safety restrictions stated.
Frequently asked questions
What types of dental materials can the D-LUX Ultraviolet Activator be used to polymerize, and why is this important for my practice?
The D-LUX is designed specifically for polymerizing light-cured dental materials such as composite resins and adhesives, which are commonly used in restorative and aesthetic dental procedures. This is important because it ensures proper curing of materials, leading to stronger, more durable restorations and better aesthetic outcomes. The device’s ultraviolet curing capability is tailored for these materials, making it a reliable choice for procedures requiring precise polymerization.
Is the D-LUX a single-use device, or can it be reused in a clinical setting? If reusable, what maintenance or care is required?
The D-LUX is a reusable device, not single-use. Since it is designed for repeated use in dental clinics, proper storage and maintenance are essential to ensure consistent performance and safety. The manufacturer recommends adhering to the provided guidelines for care, though specific details like cleaning protocols or replacement intervals are not explicitly stated in the data. Always follow the user manual to maintain functionality and longevity.
How is the D-LUX supplied, and does it come with any accessories or attachments that might be useful for different procedures?
The D-LUX is supplied as a cordless, reusable unit with a heat-dissipating aluminum construction. While the data does not specify included accessories, its design as a standalone ultraviolet curing light suggests it is intended for direct application to dental materials. Clinicians may need to verify if additional attachments or tips are available for specialized procedures, but the core functionality is built into the device itself.
Are there any special storage requirements for the D-LUX to ensure it remains functional and safe for use?
The D-LUX requires proper storage to maintain functionality, though the exact storage conditions (e.g., temperature, humidity, or environmental protection) are not detailed in the provided data. Since it is a reusable device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage. Always refer to the manufacturer’s instructions for precise storage recommendations.
What regulatory pathways has the D-LUX followed, and how does this affect its use in clinical settings?
The D-LUX has undergone FDA 510K clearance and complies with the Medical Device Regulation (MDR) under the classification of an ultraviolet activator for polymerization. This means it has been evaluated for safety and effectiveness according to regulatory standards, ensuring it meets the necessary requirements for use in dental clinics and offices. Clinicians can rely on its compliance with these pathways to confirm its suitability for polymerizing dental materials.
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: D-Lux Cordless Curing Light - DiaDent, D-Lux+ Cordless Dual-Wavelength Curing Light - DiaDent, D-Lux LED Curing Light from DiaDent Group International
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K130163 | Class II | Active |
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Manufacturer
- Manufacturer
- Diadent Group International
Sources (2)
- FDA 510(k) K130163 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026