Demi Pro
FDA 510(k) K253461 · Meta Systems Co., Ltd.
510(k) numberK253461
Submission
- Device name
- Demi Pro
- Applicant
- Meta Systems Co., Ltd.
Seongnam-Si, KR - Received
- October 7, 2025
- Decision date
- October 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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|---|---|---|---|
| K253131 | Curing Light (M-Cure 6)EBZ · Traditional | Guangzhou Rebornendo Medical Instrument Co., Ltd. | 06/18/2026SE |
| 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 |
| 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 |
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Questions and answers
When was Demi Pro cleared by the FDA?
Demi Pro (K253461) received a 510(k) decision of Substantially Equivalent on October 14, 2025, 7 days after the submission was received.
What is the product code of K253461?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.