EBZ · Activator, Ultraviolet, For Polymerization
Dental · 21 CFR 872.6070 · Class 2
Overview
| Product Code | EBZ |
|---|---|
| Device Name | Activator, Ultraviolet, For Polymerization |
| Regulation | 21 CFR 872.6070 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 213)
Showing 20 most recent of 213 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253461 | Demi Pro | Meta Systems Co., Ltd. | Oct 14, 2025 | SESE |
| K242386 | Bluemoon | Genoss Co., Ltd. | May 5, 2025 | SESE |
| K243921 | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | Apr 11, 2025 | SESE |
| K250009 | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited | Apr 10, 2025 | SESE |
| K241238 | LOOP LED Curing Light System (CLK01) | Garrison Dental Solutions, LLC | Aug 1, 2024 | SESE |
| K223414 | Curing Light, Model: MaxCure 9 | Guilin Refine Medical Instrument Co., Ltd. | Nov 15, 2023 | SESE |
| K233518 | BASE290 LED Curing Light | Handpiece Headquarters | Nov 2, 2023 | SESE |
| K223507 | CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE) | Good Doctors Co., Ltd. | Aug 4, 2023 | SESE |
| K223142 | Coltolux Comfort LED Curing Light | Dent4you AG | Dec 22, 2022 | SESE |
| K220826 | LED Curing Light | Foshan Coxo Medical Instrument Co., Ltd. | Dec 8, 2022 | SESE |
| K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | Nov 23, 2022 | SESE |
| K221194 | LEDEX | Dentmate Technology Co. , Ltd. | Sep 16, 2022 | SESE |
| K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | Feb 22, 2022 | SESE |
| K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | Mar 1, 2021 | SESE |
| K200775 | LOOP LED Curing Light System | Garrison Dental Solutions, LLC | Aug 14, 2020 | SESE |
| K200809 | D-LUX+ | DiaDent Group International | Aug 7, 2020 | SESE |
| K192233 | LED Curing Light | Foshan Cicada Dental Instrument Co, Ltd. | Feb 13, 2020 | SESE |
| K191221 | Cybird LED Curing Light | Dxm Co., Ltd. | Jan 10, 2020 | SESE |
| K192009 | LED Curing Light | Ezgo Group, Inc. | Jan 9, 2020 | SESE |
| K191865 | SmartLite Pro Modular LED Curing Light | Dentsply Sirona | Nov 20, 2019 | SESE |
Top Applicants
- Monitex Industrial Co., Ltd. — 9 clearances
- Rolence Enterprise Co. , Ltd. — 8 clearances
- Ultradent Products, Inc. — 7 clearances
- Ivoclar Vivadent, Inc. — 6 clearances
- Dentsply Intl. — 5 clearances
