LED Curing Lights (DB686 HALO)
FDA 510(k) K243921 · Foshan Coxo Medical Instrument Co., Ltd.
510(k) numberK243921
Submission
- Device name
- LED Curing Lights (DB686 HALO)
- Applicant
- Foshan Coxo Medical Instrument Co., Ltd.
Foshan, CN - Received
- December 20, 2024
- Decision date
- April 11, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EBZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253131 | Curing Light (M-Cure 6)EBZ · Traditional | Guangzhou Rebornendo Medical Instrument Co., Ltd. | 06/18/2026SE |
| K253461 | Demi ProEBZ · Traditional | Meta Systems Co., Ltd. | 10/14/2025SE |
| K242386 | BluemoonEBZ · Traditional | Genoss Co., Ltd. | 05/05/2025SE |
| K250009 | LED Curing Light (C01-X, C02-X)EBZ · Traditional | Premium Plus (Dongguan) Limited | 04/10/2025SE |
| K241238 | LOOP LED Curing Light System (CLK01)EBZ · Traditional | Garrison Dental Solutions, LLC | 08/01/2024SE |
| K223414 | Curing Light, Model: MaxCure 9EBZ · Traditional | Guilin Refine Medical Instrument Co., Ltd. | 11/15/2023SE |
| K233518 | BASE290 LED Curing LightEBZ · Traditional | Handpiece Headquarters | 11/02/2023SE |
| K223507 | CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE)EBZ · Traditional | Good Doctors Co., Ltd. | 08/04/2023SE |
| K223142 | Coltolux Comfort LED Curing LightEBZ · Traditional | Dent4you AG | 12/22/2022SE |
| K220826 | LED Curing LightEBZ · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 12/08/2022SE |
More from Foshan Coxo Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB · Traditional | 09/22/2023SE |
| K220829 | Endo MotorEKX · Traditional | 05/18/2023SE |
| K222096 | Endo Ultrasonic ActivatorELC · Traditional | 03/23/2023SE |
| K220826 | LED Curing LightEBZ · Traditional | 12/08/2022SE |
| K220831 | Dental Implantation Systems, Dental Electrical MotorsEBW · Traditional | 09/27/2022SE |
| K212178 | Root Apex LocatorLQY · Traditional | 07/20/2022SE |
Questions and answers
When was LED Curing Lights (DB686 HALO) cleared by the FDA?
LED Curing Lights (DB686 HALO) (K243921) received a 510(k) decision of Substantially Equivalent on April 11, 2025, 112 days after the submission was received.
What is the product code of K243921?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.