Curing Light, Model: MaxCure 9
FDA 510(k) clearance K223414 · decided 2023-11-15
Clearance details
- K-number
- K223414
- Device name
- Curing Light, Model: MaxCure 9
- Applicant
- Guilin Refine Medical Instrument Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-11-10
- Decision date
- 2023-11-15
- Days to decision
- 370 days
- Clearance type
- Traditional
- Product code
- EBZ
- Device class
- 2
- Regulation number
- 872.6070
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Guilin, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Curing Light (M-Cure 6) (K253131) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | 2026-06-18 |
| Demi Pro (K253461) | Meta Systems Co., Ltd. | 2025-10-14 |
| Bluemoon (K242386) | Genoss Co., Ltd. | 2025-05-05 |
| LED Curing Lights (DB686 HALO) (K243921) | Foshan Coxo Medical Instrument Co., Ltd. | 2025-04-11 |
| LED Curing Light (C01-X, C02-X) (K250009) | Premium Plus (Dongguan) Limited | 2025-04-10 |
| LOOP™ LED Curing Light System (CLK01) (K241238) | Garrison Dental Solutions, LLC | 2024-08-01 |
| BASE290 LED Curing Light (K233518) | Handpiece Headquarters | 2023-11-02 |
| CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) (K223507) | Good Doctors Co., Ltd. | 2023-08-04 |
| Coltolux Comfort LED Curing Light (K223142) | Dent4you AG | 2022-12-22 |
| LED Curing Light (K220826) | Foshan Coxo Medical Instrument Co., Ltd. | 2022-12-08 |
| CuringPen Dental Curing Light (K221152) | Changzhou Sifary Medical Technology Co., Ltd. | 2022-11-23 |
| LEDEX (K221194) | Dentmate Technology Co. , Ltd. | 2022-09-16 |
Recalls involving this device
No recalls on record reference this clearance.