Demi
FDA 510(k) K071251 · Kerr Corporation
510(k) numberK071251
Submission
- Device name
- Demi
- Applicant
- Kerr Corporation
Orange, CA, US - Received
- May 4, 2007
- Decision date
- July 26, 2007
- 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 |
| 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 |
|---|---|---|
| K252890 | ZenSeal ProKIF · Traditional | 01/07/2026SE |
| K222830 | Rainbow 360KLE · Traditional | 01/12/2023SE |
| K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowEBF · Traditional | 08/31/2022SE |
| K191548 | Nexus Universal Self-CureEMA · Traditional | 10/11/2019SE |
| K182162 | OptiBond eXTRa UniversalKLE · Traditional | 11/07/2018SE |
| K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction…MVL · Traditional | 08/08/2017SE |
| K163064 | Demi UltraEBZ · Special | 07/18/2017SE |
| K162536 | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum…MVL · Traditional | 02/03/2017SE |
| K162164 | GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction CordMVL · Traditional | 01/13/2017SE |
| K162436 | EndoVac PureNYL · Traditional | 12/21/2016SE |
Questions and answers
When was Demi cleared by the FDA?
Demi (K071251) received a 510(k) decision of Substantially Equivalent on July 26, 2007, 83 days after the submission was received.
What is the product code of K071251?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.