CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223507 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 CL-DP40 (Dr’s Light PRIME and CHOICE) is an ultraviolet activator designed for polymerizing dental composites and adhesives. It delivers controlled curing light output to ensure proper hardening of restorative materials in dental procedures, adhering to the classification of an ultraviolet activator for polymerization as defined by regulatory standards.
These devices are intended for use in dental clinics and offices, supplied as single-use or reusable units depending on the model. Both variants are classified as Class II devices under FDA regulations and comply with MDR requirements. The CL-DP40 PRIME and CHOICE feature adjustable curing tips for versatility in treatment applications, with no specific MRI safety restrictions noted. Storage conditions require protection from moisture and extreme temperatures, and they are authorized under FDA 510(k) clearance (K223507) and MDR compliance.
Frequently asked questions
What are the key differences between the CL-DP40 PRIME and CHOICE models in terms of usage flexibility?
The CL-DP40 PRIME and CHOICE models both serve as ultraviolet activators for polymerizing dental composites and adhesives, but the CHOICE variant is explicitly noted as supplied in either single-use or reusable configurations. This distinction allows clinicians to choose based on their practice’s needs—whether they prefer the convenience of single-use devices or the cost efficiency of reusable units. Both models feature adjustable curing tips, ensuring versatility in dental treatment applications.
How should I store the CL-DP40 devices to maintain their performance and longevity?
The CL-DP40 devices require protection from moisture and extreme temperatures during storage. This ensures their curing light output remains consistent and reliable for proper polymerization of dental materials. Always store them in a dry environment, away from direct sunlight or humidity, to preserve their functionality.
Are there any MRI safety restrictions or considerations for using the CL-DP40 devices?
The CL-DP40 (Dr’s Light PRIME and CHOICE) devices do not have specific MRI safety restrictions noted in their documentation. However, since they are designed for dental use, it’s always advisable to follow standard operating procedures for handling electronic devices in proximity to MRI environments, even if no explicit restrictions are listed.
What regulatory pathways have the CL-DP40 devices undergone, and what does this mean for clinicians?
The CL-DP40 devices have undergone FDA 510(k) clearance (K223507) and comply with the EU’s Medical Device Regulation (MDR). This means they meet U.S. and EU standards for safety and effectiveness as ultraviolet activators for dental composites and adhesives. Clinicians can rely on these regulatory clearances as evidence of the devices’ compliance with rigorous quality and performance requirements.
What types of dental procedures are these devices intended to support, and how do the adjustable tips help?
The CL-DP40 devices are designed to support a wide range of dental procedures involving the polymerization of composites and adhesives, such as fillings, bonding, and other restorative treatments. The adjustable curing tips allow clinicians to direct the ultraviolet light precisely to different treatment areas, accommodating various angles and depths for optimal curing results.
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: Dr's Light PRIME - Good Doctors Germany, CL-DP40 (Dr's Light PRIME), CL-DP40 (Dr's Light CHOICE) (K223507) — FDA ..., PDF GDBR-CL-DP40(Brochure for Dr_s Light PRIME)(Eng) - Good Doctors Germany, K223507 FDA 510(k) - CL-DP40 (Dr's Light PRIME), Dr's Light PRIME Curing Light Slim & Wide CL-DP40 Set
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 | K223507 | Class II | Active |
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Manufacturer
- Manufacturer
- Good Doctors Co., Ltd.
Sources (2)
- FDA 510(k) K223507 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026