LED Curing Lights DB686 HALO
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243921 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 Lights DB686 HALO is a dental device designed for polymerizing light-cured restorative materials, such as composites and resins, in dental procedures. It emits high-intensity light to initiate and accelerate the curing process, ensuring proper hardening of dental fillings and other restorative treatments.
This device is intended for use in dental clinics and offices, supplied as a reusable medical instrument. It operates under non-sterile conditions but must be cleaned and maintained according to manufacturer guidelines. The LED Curing Lights DB686 HALO holds FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for dental curing lights. The device is classified under Class II (device class=2) and is regulated under the FDA’s regulation number 872.6070.
Frequently asked questions
What is the primary purpose of the LED Curing Lights (DB686 HALO) in dental procedures?
The LED Curing Lights (DB686 HALO) is designed specifically to polymerize light-cured restorative materials, such as dental composites and resins. It emits high-intensity light to initiate and accelerate the curing process, ensuring that dental fillings and other restorative treatments harden properly during procedures.
Is the LED Curing Lights (DB686 HALO) intended for single-use or reusable applications?
The device is supplied as a reusable medical instrument, meaning it is intended for repeated use in dental clinics and offices. However, it must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper functionality and hygiene.
What regulatory approvals does the LED Curing Lights (DB686 HALO) hold, and how does this affect its use?
The device holds FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for dental curing lights. These approvals indicate compliance with safety and performance requirements, allowing its use in dental practices where such devices are legally permitted.
How should the LED Curing Lights (DB686 HALO) be stored to maintain its effectiveness?
While the device itself is not sterile, it must be stored in a clean, dry environment to prevent damage or contamination. The manufacturer’s maintenance guidelines should be followed to ensure optimal performance, though specific storage conditions (e.g., temperature or humidity) are not detailed in the provided data.
Does the LED Curing Lights (DB686 HALO) come with multiple models or sizes, and if so, what variations are available?
The provided data does not specify distinct models or sizes for the DB686 HALO, but the associated product codes (e.g., EBZ) and regulatory filings suggest it may be categorized under broader dental curing light classifications. For exact variations, refer to the manufacturer’s documentation or contact support.
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.
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 | K243921 | Class II | Active |
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Manufacturer
- Manufacturer
- Foshan COXO Medical Instrument Co., Ltd.
Sources (2)
- FDA 510(k) K243921 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026