Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart G — Miscellaneous Devices](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 872.6070](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6070) → EBZ — Activator, Ultraviolet, For Polymerization

# EBZ · Activator, Ultraviolet, For Polymerization

_Dental · 21 CFR 872.6070 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/EBZ

## Overview

- **Product Code:** EBZ
- **Device Name:** Activator, Ultraviolet, For Polymerization
- **Regulation:** [21 CFR 872.6070](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6070)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **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](/device/K253461.md) | Demi Pro | Meta Systems Co., Ltd. | Oct 14, 2025 | SESE |
| [K242386](/device/K242386.md) | Bluemoon | Genoss Co., Ltd. | May 5, 2025 | SESE |
| [K243921](/device/K243921.md) | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | Apr 11, 2025 | SESE |
| [K250009](/device/K250009.md) | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited | Apr 10, 2025 | SESE |
| [K241238](/device/K241238.md) | LOOP™ LED Curing Light System (CLK01) | Garrison Dental Solutions, LLC | Aug 1, 2024 | SESE |
| [K223414](/device/K223414.md) | Curing Light, Model: MaxCure 9 | Guilin Refine Medical Instrument Co., Ltd. | Nov 15, 2023 | SESE |
| [K233518](/device/K233518.md) | BASE290 LED Curing Light | Handpiece Headquarters | Nov 2, 2023 | SESE |
| [K223507](/device/K223507.md) | CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) | Good Doctors Co., Ltd. | Aug 4, 2023 | SESE |
| [K223142](/device/K223142.md) | Coltolux Comfort LED Curing Light | Dent4you AG | Dec 22, 2022 | SESE |
| [K220826](/device/K220826.md) | LED Curing Light | Foshan Coxo Medical Instrument Co., Ltd. | Dec 8, 2022 | SESE |
| [K221152](/device/K221152.md) | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | Nov 23, 2022 | SESE |
| [K221194](/device/K221194.md) | LEDEX | Dentmate Technology Co. , Ltd. | Sep 16, 2022 | SESE |
| [K220471](/device/K220471.md) | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | Feb 22, 2022 | SESE |
| [K210550](/device/K210550.md) | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | Mar 1, 2021 | SESE |
| [K200775](/device/K200775.md) | LOOP LED Curing Light System | Garrison Dental Solutions, LLC | Aug 14, 2020 | SESE |
| [K200809](/device/K200809.md) | D-LUX+ | DiaDent Group International | Aug 7, 2020 | SESE |
| [K192233](/device/K192233.md) | LED Curing Light | Foshan Cicada Dental Instrument Co, Ltd. | Feb 13, 2020 | SESE |
| [K191221](/device/K191221.md) | Cybird LED Curing Light | Dxm Co., Ltd. | Jan 10, 2020 | SESE |
| [K192009](/device/K192009.md) | LED Curing Light | Ezgo Group, Inc. | Jan 9, 2020 | SESE |
| [K191865](/device/K191865.md) | 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

---

**Source:** [https://fda.innolitics.com/productcode/EBZ](https://fda.innolitics.com/productcode/EBZ)

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