EBZ
- Product code
- EBZ
- Device name
- Activator, Ultraviolet, For Polymerization
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.6070
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 214
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253131 | 2026-06-18 | Guangzhou Rebornendo Medical Instrumen | Curing Light (M-Cure 6) | |
| K253461 | 2025-10-14 | Meta Systems Co., Ltd. | Demi Pro | |
| K242386 | 2025-05-05 | Genoss Co., Ltd. | Bluemoon | |
| K243921 | 2025-04-11 | Foshan Coxo Medical Instrument Co., Lt | LED Curing Lights (DB686 HALO) | |
| K250009 | 2025-04-10 | Premium Plus (Dongguan) Limited | LED Curing Light (C01-X, C02-X) | |
| K241238 | 2024-08-01 | Garrison Dental Solutions, LLC | LOOP LED Curing Light System (CLK01) | |
| K223414 | 2023-11-15 | Guilin Refine Medical Instrument Co., | Curing Light, Model: MaxCure 9 | |
| K233518 | 2023-11-02 | Handpiece Headquarters | BASE290 LED Curing Light | — |
Official FDA classification page: EBZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).