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/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/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](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K253461.md) | Demi Pro | Meta Systems Co., Ltd. | Oct 14, 2025 | SESE | | [K242386](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K242386.md) | Bluemoon | Genoss Co., Ltd. | May 5, 2025 | SESE | | [K243921](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K243921.md) | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | Apr 11, 2025 | SESE | | [K250009](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K250009.md) | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited | Apr 10, 2025 | SESE | | [K241238](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K241238.md) | LOOP™ LED Curing Light System (CLK01) | Garrison Dental Solutions, LLC | Aug 1, 2024 | SESE | | [K223414](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K223414.md) | Curing Light, Model: MaxCure 9 | Guilin Refine Medical Instrument Co., Ltd. | Nov 15, 2023 | SESE | | [K233518](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K233518.md) | BASE290 LED Curing Light | Handpiece Headquarters | Nov 2, 2023 | SESE | | [K223507](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K223507.md) | CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) | Good Doctors Co., Ltd. | Aug 4, 2023 | SESE | | [K223142](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K223142.md) | Coltolux Comfort LED Curing Light | Dent4you AG | Dec 22, 2022 | SESE | | [K220826](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K220826.md) | LED Curing Light | Foshan Coxo Medical Instrument Co., Ltd. | Dec 8, 2022 | SESE | | [K221152](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K221152.md) | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | Nov 23, 2022 | SESE | | [K221194](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K221194.md) | LEDEX | Dentmate Technology Co. , Ltd. | Sep 16, 2022 | SESE | | [K220471](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K220471.md) | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | Feb 22, 2022 | SESE | | [K210550](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K210550.md) | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | Mar 1, 2021 | SESE | | [K200775](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K200775.md) | LOOP LED Curing Light System | Garrison Dental Solutions, LLC | Aug 14, 2020 | SESE | | [K200809](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K200809.md) | D-LUX+ | DiaDent Group International | Aug 7, 2020 | SESE | | [K192233](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K192233.md) | LED Curing Light | Foshan Cicada Dental Instrument Co, Ltd. | Feb 13, 2020 | SESE | | [K191221](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K191221.md) | Cybird LED Curing Light | Dxm Co., Ltd. | Jan 10, 2020 | SESE | | [K192009](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/K192009.md) | LED Curing Light | Ezgo Group, Inc. | Jan 9, 2020 | SESE | | [K191865](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ/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/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com