LED Curing Light (C01-X, C02-X)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250009 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 (C01-X, C02-X) is a dental device classified as an ultraviolet activator for polymerization, designed to cure light-activated dental resins and composites. It employs blue LED technology to initiate and complete the polymerization process during restorative procedures, ensuring proper hardening of dental materials.
This device is intended for use in clinical dental settings by dental professionals. The C01-X features a 11 mm hardened glass lens for uniform light distribution, while the C02-X includes a 10 mm direct light source head, both of which are rotatable 360° for accessibility. The device is non-sterile, single-use components (such as the light source head) may be replaceable, and it is regulated under FDA 510(k) clearance and MDR authorizations. Dimensions include a length of 265 mm for the C01-X and a weight of 175 g.
Frequently asked questions
What is the primary purpose of the LED Curing Light (C01-X, C02-X) in dental procedures?
The LED Curing Light (C01-X, C02-X) is designed to cure light-activated dental resins and composites by initiating and completing the polymerization process during restorative procedures. This ensures proper hardening of dental materials, which is essential for the longevity and integrity of fillings, crowns, or other restorative treatments.
Are the light source heads for the C01-X and C02-X models reusable or single-use, and how does this affect their sterility?
The LED Curing Light device itself is non-sterile, but the light source heads (such as the 11 mm hardened glass lens for C01-X or the 10 mm direct light source head for C02-X) are intended for single-use or may be replaceable. Since they are not sterile, they must be handled in accordance with clinical protocols to prevent cross-contamination between patients.
What are the key differences between the C01-X and C02-X models in terms of design and functionality?
The C01-X features a 11 mm hardened glass lens for uniform light distribution, while the C02-X includes a 10 mm direct light source head. Both models share the same 360° rotational capability for accessibility, but the lens type and size may influence light intensity and application precision depending on the clinical scenario. The C02-X’s direct light source may be preferable for targeted curing.
How should the LED Curing Light be stored, and are there any specific handling requirements?
While the device’s storage instructions aren’t explicitly detailed, typical LED curing lights require protection from extreme temperatures, moisture, and physical damage. Since the light source heads are replaceable or single-use, they should be stored in a clean, dry environment to maintain functionality. Always follow manufacturer guidelines for proper handling and storage to ensure optimal performance and longevity of the device.
What regulatory pathways has the LED Curing Light (C01-X, C02-X) undergone, and what does this imply for its use?
The device has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorizations, confirming it meets regulatory standards for safety and effectiveness in its intended use. This implies it has been evaluated by competent authorities and is legally marketable in jurisdictions adhering to these frameworks, though clinicians should always verify local compliance requirements before use.
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: New | Premium Plus Curing Light C01-X/ C02-X, LED Curing Light (C01-X, C02-X) (K250009) — FDA 510 (k) | Innolitics, PDF HARDENED GLASS LENS COLLIMATED C01-X LED CURING LIGHT 11 mm UNIFORM ...
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 | K250009 | Class II | Active |
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Manufacturer
- Manufacturer
- Premium Plus (Dongguan) Limited
Sources (2)
- FDA 510(k) K250009 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026