Curing Light, Model: MaxCure 9
FDA 510(k) K223414 · Guilin Refine Medical Instrument Co., Ltd.
510(k) numberK223414
Submission
- Device name
- Curing Light, Model: MaxCure 9
- Applicant
- Guilin Refine Medical Instrument Co., Ltd.
Guilin, CN - Received
- November 10, 2022
- Decision date
- November 15, 2023
- 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 |
| K243921 | LED Curing Lights (DB686 HALO)EBZ · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 04/11/2025SE |
| 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 |
| 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 |
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Questions and answers
When was Curing Light, Model: MaxCure 9 cleared by the FDA?
Curing Light, Model: MaxCure 9 (K223414) received a 510(k) decision of Substantially Equivalent on November 15, 2023, 370 days after the submission was received.
What is the product code of K223414?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.