Activator, Ultraviolet, For Polymerization
Regulation 872.6070
1510(k)s in 12 months (214 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in EBZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ivoclar Vivadent, AG | 8 | 1 |
| Monitex Industrial Co., Ltd. | 9 | 0 |
| Rolence Enterprise Co. , Ltd. | 8 | 0 |
| Ultradent Products, Inc. | 7 | 0 |
| Kerr Corp. | 6 | 0 |
| Dentsply Intl. | 5 | 0 |
| 3M Company | 4 | 0 |
| Apoza Enterprise Co., Ltd. | 4 | 0 |
| Dentmate Technology Co. , Ltd. | 4 | 0 |
| Dxm Co., Ltd. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 18, 2026 | K253131 | Curing Light (M-Cure 6) Guangzhou Rebornendo Medical Instrument Co., Ltd., CN | EBZ |
| Oct 14, 2025 | K253461 | Demi Pro Meta Systems Co., Ltd., KR | EBZ |
| May 5, 2025 | K242386 | Bluemoon Genoss Co., Ltd., CN | EBZ |
| Apr 11, 2025 | K243921 | LED Curing Lights (DB686 HALO) Foshan Coxo Medical Instrument Co., Ltd., CN | EBZ |
| Apr 10, 2025 | K250009 | LED Curing Light (C01-X, C02-X) Premium Plus (Dongguan) Limited, CN | EBZ |
| Aug 1, 2024 | K241238 | LOOP LED Curing Light System (CLK01) Garrison Dental Solutions, LLC | EBZ |
| Nov 15, 2023 | K223414 | Curing Light, Model: MaxCure 9 Guilin Refine Medical Instrument Co., Ltd., CN | EBZ |
| Nov 2, 2023 | K233518 | BASE290 LED Curing Light Handpiece Headquarters | EBZ |
| Aug 4, 2023 | K223507 | CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE) Good Doctors Co., Ltd., KR | EBZ |
| Dec 22, 2022 | K223142 | Coltolux Comfort LED Curing Light Dent4you AG, CH | EBZ |
| Dec 8, 2022 | K220826 | LED Curing Light Foshan Coxo Medical Instrument Co., Ltd., CN | EBZ |
| Nov 23, 2022 | K221152 | CuringPen Dental Curing Light Changzhou Sifary Medical Technology Co., Ltd., CN | EBZ |
| Sep 16, 2022 | K221194 | LEDEX Dentmate Technology Co. , Ltd., TW | EBZ |
| Feb 22, 2022 | K220471 | VALO X, VALO X Accessory Lenses Ultradent Products, Inc. | EBZ |
| Mar 1, 2021 | K210550 | VALO Grand Corded and Accessory Lenses Ultradent Products, Inc. | EBZ |
| Aug 14, 2020 | K200775 | LOOP LED Curing Light System Garrison Dental Solutions, LLC | EBZ |
| Aug 7, 2020 | K200809 | D-LUX+ DiaDent Group International, KR | EBZ |
| Feb 13, 2020 | K192233 | LED Curing Light Foshan Cicada Dental Instrument Co, Ltd., CN | EBZ |
| Jan 10, 2020 | K191221 | Cybird LED Curing Light Dxm Co., Ltd., KR | EBZ |
| Jan 9, 2020 | K192009 | LED Curing Light Ezgo Group, Inc. | EBZ |
| Nov 20, 2019 | K191865 | SmartLite Pro Modular LED Curing Light Dentsply Sirona | EBZ |
| Jul 3, 2019 | K190272 | Bluephase PowerCure Ivoclar Vivadent, AG, LI | EBZ |
| Apr 29, 2019 | K190627 | VALO Grand Corded Ultradent Products, Inc. | EBZ |
| Apr 19, 2019 | K180065 | FUSION Plus Curing Light Dentlight, Inc. | EBZ |
| Apr 1, 2019 | K181597 | Le'Pen Kmihh, Ltd., IL | EBZ |
| May 29, 2018 | K173157 | Dr's Light2 Good Doctors Co., Ltd., KR | EBZ |
| Jan 24, 2018 | K173876 | Cybird LED Curing Light Dxm Co., Ltd., KR | EBZ |
| Nov 27, 2017 | K161855 | LED Curing Light Monitex Industrial Co., Ltd., TW | EBZ |
| Aug 16, 2017 | K172426 | Clear Blue Digi LED Curing Light Promident, LLC | EBZ |
| Aug 8, 2017 | K170529 | Delight, Delight ortho, B&Lite S Dentall Co., Ltd., KR | EBZ |
| Jul 18, 2017 | K163064 | Demi Ultra Kerr Corporation | EBZ |
| Jun 8, 2017 | K170101 | Valiant Curing Light Inter-Med/Vista Dental Products | EBZ |
| Apr 7, 2017 | K152192 | LED Curing Light Monitex Industrial Co., Ltd., TW | EBZ |
| Apr 4, 2017 | K163613 | Bluephase Style 20i Ivoclar Vivadent, AG, LI | EBZ |
| Jan 19, 2017 | K163605 | LEDEX WL070+ Dentmate Technology Co. , Ltd., TW | EBZ |
| Aug 22, 2016 | K153514 | Premium Plus C01/C02 LED Curing Light Premium Plus International Limited, CN | EBZ |
| Jul 13, 2016 | K160551 | VALO Grand Ultradent Products, Inc. | EBZ |
| Jun 28, 2016 | K153078 | LED Curing Light GT-2000 Monitex Industrial Co., Ltd., TW | EBZ |
| Jun 23, 2016 | K153018 | CELALUX 3 Voco GmbH, DE | EBZ |
| Dec 31, 2015 | K150585 | Ascent 3D CAO Group, Inc. | EBZ |
| Nov 13, 2015 | K152936 | Sirius Max Dental Diode Curing Light National Dental, Inc., CA | EBZ |
| Aug 24, 2015 | K150205 | LED Curing Light Monitex Industrial Co., Ltd., TW | EBZ |
| Aug 3, 2015 | K140432 | HI-LIGHT, HI-LIGHT PLUS Dentall Corporation | EBZ |
| Oct 7, 2014 | K133040 | LED CURING LIGHT Monitex Industrial Co., Ltd., TW | EBZ |
| Jul 24, 2014 | K140281 | FLEXI-LUME LED SYSTEM Epic Medical Concepts & Innovations | EBZ |
| Apr 11, 2014 | K131906 | SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE Satelec - Acteon Group | EBZ |
| Oct 3, 2013 | K131042 | LEDEX Dentmate Technology Co. , Ltd., TW | EBZ |
| Aug 16, 2013 | K130163 | D-LUX DiaDent Group International, KR | EBZ |
| Mar 20, 2013 | K123468 | DEMI ULTRA Kerr Corporation | EBZ |
| Nov 27, 2012 | K121093 | D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 Dxm Co., Ltd. | EBZ |
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