Smartlite PS Pen-Style LED Curing Light
FDA 510(k) K041372 · Dentsply International
510(k) numberK041372
Submission
- Device name
- Smartlite PS Pen-Style LED Curing Light
- Applicant
- Dentsply International
York, PA, US - Received
- May 24, 2004
- Decision date
- June 24, 2004
- 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 |
|---|---|---|
| K160207 | ATLANTIS ISUS Implant SuprastructuresNHA · Traditional | 09/21/2016SE |
| K160232 | Disposable Barrier Sleeves and CoversPEM · Traditional | 06/07/2016SE |
| K151439 | Atlantis IsusNHA · Traditional | 02/19/2016SE |
| K152247 | ATLANTIS CrownEIH · Traditional | 01/29/2016SE |
| K151039 | ATLANTIS Abutment for NobelActive 3.0NHA · Traditional | 01/14/2016SE |
| K151619 | Prime&Bond Elect Universal Dental AdhesiveKLE · Traditional | 10/30/2015SE |
| K150535 | Cavitron Touch Ultrasonic Scaling SystemELC · Traditional | 06/16/2015SE |
| K142178 | Proroot Mta White, Proroot Mta GrayKIF · Traditional | 02/26/2015SE |
| K131907 | Raypex 6LQY · Traditional | 01/31/2014SE |
| K131644 | Ankylos Syncone Abutment 5(DEGREE)NHA · Traditional | 01/22/2014SE |
Questions and answers
When was Smartlite PS Pen-Style LED Curing Light cleared by the FDA?
Smartlite PS Pen-Style LED Curing Light (K041372) received a 510(k) decision of Substantially Equivalent on June 24, 2004, 31 days after the submission was received.
What is the product code of K041372?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.