LED Curing Light
FDA 510(k) K161855 · Monitex Industrial Co., Ltd.
510(k) numberK161855
Submission
- Device name
- LED Curing Light
- Applicant
- Monitex Industrial Co., Ltd.
New Taipei City, TW - Received
- July 6, 2016
- Decision date
- November 27, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
More from Dent4you AG
| 510(k) | Device | Decision |
|---|---|---|
| K152192 | LED Curing LightEBZ · Traditional | 04/07/2017SE |
| K153078 | LED Curing Light GT-2000EBZ · Traditional | 06/28/2016SE |
| K150205 | LED Curing LightEBZ · Traditional | 08/24/2015SE |
| K133040 | LED Curing LightEBZ · Traditional | 10/07/2014SE |
| K091887 | LED Curing Light, Model GT-1500EBZ · Traditional | 09/18/2009SE |
| K080035 | LED Curing LightEBZ · Traditional | 03/03/2008SE |
| K060646 | Blue Luxcer Curing Light, Models M-830, M-835 and M-855EBZ · Traditional | 04/21/2006SE |
| K051203 | BluelexEBZ · Traditional | 05/25/2005SE |
Questions and answers
When was LED Curing Light cleared by the FDA?
LED Curing Light (K161855) received a 510(k) decision of Substantially Equivalent on November 27, 2017, 509 days after the submission was received.
What is the product code of K161855?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.