Identifiers
- 510(k) Number
- K093751 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 device is a dental curing light, specifically the CL-DC20 and CL-DC21 models, designed for the polymerization of dental composites using visible light. It is classified as a Class II medical device under FDA regulation number 872.6070 and has received traditional 510(k) clearance as substantially equivalent to a predicate device.
The device is supplied as a reusable handpiece unit with dimensions of 232 x 40 x 26 mm and a weight of 107 g (including battery). It operates with selectable curing modes, light intensity, and time settings, and is intended for use in dental clinical settings. Storage and handling should follow the manufacturer's instructions as detailed in the user manual.
Frequently asked questions
What is the CL-DC20/CL-DC21 dental curing light used for?
The CL-DC20 and CL-DC21 models are dental curing lights designed for the polymerization of dental composites using visible light in clinical dental settings.
Is the CL-DC20/CL-DC21 device reusable or single-use?
The device is supplied as a reusable handpiece unit, meaning it is intended for multiple uses after proper cleaning and maintenance according to the manufacturer's instructions.
What are the physical dimensions and weight of the CL-DC20/CL-DC21 curing light?
The device has dimensions of 232 x 40 x 26 mm and weighs 107 grams, including the battery, making it a compact and lightweight handheld unit for dental procedures.
How should the CL-DC20/CL-DC21 be stored and handled?
Storage and handling should follow the manufacturer's instructions as detailed in the user manual to ensure proper function, longevity, and safety of the device.
What regulatory pathway was used for the CL-DC20/CL-DC21 device?
The device received traditional 510(k) clearance from the FDA, demonstrating it is substantially equivalent to a legally marketed predicate device under regulation number 872.6070.
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: CL-DC20, CL-DC21 (K093751) — FDA 510 (k) | Innolitics, Cl-dc20, Cl-dc21 510 (k) FDA Premarket Notification K093751 GOOD ..., PDF GDUM-CL-DC20(User Manual for Drs Light Clever ... - Good Doctors Germany, Dr's Light Clever - Good Doctors Germany
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093751 | Class II | Active |
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Manufacturer
- Manufacturer
- Good Doctors Co., Ltd.
Sources (1)
- FDA 510(k) K093751 24 fields · synced Sep 19, 2026