EBZ
214 FDA 510(k) clearances · Product code
65 daysmedian time to decision
231 days90th percentile
214clearances measured
FDA profile
- Official device name
- Activator, Ultraviolet, For Polymerization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.6070
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2010: 5 · 2011: 18 · 2012: 20 · 2013: 27 · 2014: 31 · 2015: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Curing Light (M-Cure 6) (K253131) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | 2026-06-18 |
| Demi Pro (K253461) | Meta Systems Co., Ltd. | 2025-10-14 |
| Bluemoon (K242386) | Genoss Co., Ltd. | 2025-05-05 |
| LED Curing Lights (DB686 HALO) (K243921) | Foshan Coxo Medical Instrument Co., Ltd. | 2025-04-11 |
| LED Curing Light (C01-X, C02-X) (K250009) | Premium Plus (Dongguan) Limited | 2025-04-10 |
| LOOP™ LED Curing Light System (CLK01) (K241238) | Garrison Dental Solutions, LLC | 2024-08-01 |
| Curing Light, Model: MaxCure 9 (K223414) | Guilin Refine Medical Instrument Co., Ltd. | 2023-11-15 |
| BASE290 LED Curing Light (K233518) | Handpiece Headquarters | 2023-11-02 |
| CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) (K223507) | Good Doctors Co., Ltd. | 2023-08-04 |
| Coltolux Comfort LED Curing Light (K223142) | Dent4you AG | 2022-12-22 |
| LED Curing Light (K220826) | Foshan Coxo Medical Instrument Co., Ltd. | 2022-12-08 |
| CuringPen Dental Curing Light (K221152) | Changzhou Sifary Medical Technology Co., Ltd. | 2022-11-23 |
| LEDEX (K221194) | Dentmate Technology Co. , Ltd. | 2022-09-16 |
| VALO X, VALO X Accessory Lenses (K220471) | Ultradent Products, Inc. | 2022-02-22 |
| VALO Grand Corded and Accessory Lenses (K210550) | Ultradent Products, Inc. | 2021-03-01 |
| LOOP LED Curing Light System (K200775) | Garrison Dental Solutions, LLC | 2020-08-14 |
| D-LUX+ (K200809) | DiaDent Group International | 2020-08-07 |
| LED Curing Light (K192233) | Foshan Cicada Dental Instrument Co, Ltd. | 2020-02-13 |
| Cybird LED Curing Light (K191221) | Dxm Co., Ltd. | 2020-01-10 |
| LED Curing Light (K192009) | Ezgo Group, Inc. | 2020-01-09 |
| SmartLite Pro Modular LED Curing Light (K191865) | Dentsply Sirona | 2019-11-20 |
| Bluephase PowerCure (K190272) | Ivoclar Vivadent, AG | 2019-07-03 |
| VALO Grand Corded (K190627) | Ultradent Products, Inc. | 2019-04-29 |
| FUSION Plus Curing Light (K180065) | Dentlight, Inc. | 2019-04-19 |
| Le'Pen (K181597) | Kmihh, Ltd. | 2019-04-01 |
| Dr's Light2 (K173157) | Good Doctors Co., Ltd. | 2018-05-29 |
| Cybird LED Curing Light (K173876) | Dxm Co., Ltd. | 2018-01-24 |
| LED Curing Light (K161855) | Monitex Industrial Co., Ltd. | 2017-11-27 |
| Clear Blue Digi LED Curing Light (K172426) | Promident, LLC | 2017-08-16 |
| Delight, Delight ortho, B&Lite S (K170529) | Dentall Co., Ltd. | 2017-08-08 |
| Demi Ultra (K163064) | Kerr Corporation | 2017-07-18 |
| Valiant Curing Light (K170101) | Inter-Med/Vista Dental Products | 2017-06-08 |
| LED Curing Light (K152192) | Monitex Industrial Co., Ltd. | 2017-04-07 |
| Bluephase Style 20i (K163613) | Ivoclar Vivadent, AG | 2017-04-04 |
| LEDEX WL070+ (K163605) | Dentmate Technology Co. , Ltd. | 2017-01-19 |
| Premium Plus C01/C02 LED Curing Light (K153514) | Premium Plus International Limited | 2016-08-22 |
| VALO Grand (K160551) | Ultradent Products, Inc. | 2016-07-13 |
| LED Curing Light GT-2000 (K153078) | Monitex Industrial Co., Ltd. | 2016-06-28 |
| CELALUX 3 (K153018) | Voco GmbH | 2016-06-23 |
| Ascent 3D (K150585) | CAO Group, Inc. | 2015-12-31 |
| Sirius Max Dental Diode Curing Light (K152936) | National Dental, Inc. | 2015-11-13 |
| LED Curing Light (K150205) | Monitex Industrial Co., Ltd. | 2015-08-24 |
| HI-LIGHT, HI-LIGHT PLUS (K140432) | Dentall Corporation | 2015-08-03 |
| LED CURING LIGHT (K133040) | Monitex Industrial Co., Ltd. | 2014-10-07 |
| FLEXI-LUME LED SYSTEM (K140281) | Epic Medical Concepts & Innovations | 2014-07-24 |
| SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE (K131906) | Satelec - Acteon Group | 2014-04-11 |
| LEDEX (K131042) | Dentmate Technology Co. , Ltd. | 2013-10-03 |
| D-LUX (K130163) | DiaDent Group International | 2013-08-16 |
| DEMI ULTRA (K123468) | Kerr Corporation | 2013-03-20 |
| D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 (K121093) | Dxm Co., Ltd. | 2012-11-27 |
| BLUEPHASE STYLE (K110756) | Ivoclar Vivadent, Inc. | 2011-08-29 |
| VALO CORDLESS (K110582) | Ultradent Products, Inc. | 2011-04-28 |
| SOLSTICE (K102621) | Kerr Corporation | 2011-01-28 |
| CL-DC20, CL-DC21 (K093751) | Good Doctors Co., Ltd. | 2010-02-24 |
| STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS (K092951) | Mectron S.P.A. | 2009-12-07 |
| LED CURING LIGHT, MODEL GT-1500 (K091887) | Monitex Industrial Co., Ltd. | 2009-09-18 |
| BLUEPHASE 20I (K091020) | Ivoclar Vivadent, Inc. | 2009-06-12 |
| VALO, MODEL 5919 (K083647) | Ultradent Products, Inc. | 2009-01-23 |
| LEDEX, MODEL: WL-070 (K082408) | Dentmate Technology Co. , Ltd. | 2008-12-03 |
| SAPPHIRE PLASMA ARC DENTAL CURING LIGHT (K081287) | Den-Mat Holdings, LLC | 2008-11-21 |
| BONART ART-L5 LED CORDLESS CURING LIGHT (K082971) | Bonart Co., Ltd. | 2008-11-13 |
| LED.L, LED.M, LED.G, LED.B (K080025) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2008-03-19 |
| LED CURING LIGHT (K080035) | Monitex Industrial Co., Ltd. | 2008-03-03 |
| FLASHLITE REBEL* (K073518) | Discus Dental, Inc. | 2007-12-20 |
| I LIGHT (K072807) | Dent'N CO | 2007-11-21 |
| MINI LED AUTOFOCUS (K072181) | Satelec | 2007-09-19 |
| DOCTOR'S LIGHT LED DENTAL CURING LIGHT (K071908) | Good Doctors Co., Ltd. | 2007-08-23 |
| DEEP BLUE (K071722) | E.M.S Electro Medical Systems S.A | 2007-08-10 |
| DEMI (K071251) | Kerr Corporation | 2007-07-26 |
| EASY CURING PEN-STYLE LED CURING LIGHT (K063659) | Dent Corp. Research & Development | 2007-04-30 |
| APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W (K070373) | Apoza Enterprise Co., Ltd. | 2007-03-02 |
| PENCURE, MODEL VL-7 (K063529) | J. Morita USA, Inc. | 2007-01-05 |
| BONART ART-L3 LED CURING LIGHT (K062289) | Bonart Co., Ltd. | 2007-01-03 |
| DEMETRON A.2 (K063116) | Sybron Dental Specialties | 2006-12-05 |
| AURORA (K063003) | Parkell, Inc. | 2006-11-28 |
| TUTU 7, MODEL IV-T22 (K062735) | Invisible Technology Co., Ltd. | 2006-10-27 |
| SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L (K061658) | Dentall Corp. | 2006-09-18 |
| LED PROLUX 770 (K061695) | Peng Lim Enterprise Co., Ltd. | 2006-09-14 |
| CALSET COMPOSITE HEATER (K061395) | Addent, Inc. | 2006-06-23 |
| PALMLIGHT 10, MODEL 001-00030 (K061341) | CAO Group, Inc. | 2006-06-12 |
| BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 (K060646) | Monitex Industrial Co., Ltd. | 2006-04-21 |
| BISCO LED (K052122) | Bisco, Inc. | 2006-03-29 |
| AVANTE LED CURING UNIT, MODEL N44 (K052349) | Pentron Clinical Technologies | 2005-10-21 |
| FUSION CURING LIGHT (K052593) | Dentlight, Inc. | 2005-09-28 |
| BLUEPHASE 16I (K051782) | Ivoclar Vivadent, Inc. | 2005-09-20 |
| JETLITE 5000 (K051780) | J. Morita USA, Inc. | 2005-07-28 |
| SKYLIGHT LED CURING LIGHT (K051571) | Dmetec.Co., Ltd. | 2005-07-19 |
| L.E. DEMETRON II (K051545) | Kerr Corporation (Danbury) | 2005-07-18 |
| BLUELEX (K051203) | Monitex Industrial Co., Ltd. | 2005-05-25 |
| G-LIGHT (K050059) | GC America, Inc. | 2005-02-03 |
| DVI CURING LIGHT (K043530) | Designs For Vision, Inc. | 2005-01-25 |
| NOVA-PULSE (K043302) | Nova Ranger, Inc. | 2005-01-03 |
| DEMETRON IDS CURING LIGHT (K042888) | Kerr Corp. | 2004-11-10 |
| SAVEDENT BLUE (K042196) | Denfotex Light Systems, Ltd. | 2004-11-01 |
| CYBIRD LED CURING LIGHT (K042703) | Dxm Co., Ltd. | 2004-10-12 |
| TRANSLUX POWER BLUE (K042199) | Heraeus Kulzer,GmbH | 2004-09-08 |
| SMARTLITE PS PEN-STYLE LED CURING LIGHT (K041372) | Dentsply International | 2004-06-24 |
| LED TURBO-PEN (K041303) | Apoza Enterprise Co., Ltd. | 2004-06-18 |
| HILUX LEDMAX 3 (K040956) | First Medical Infection Control Associates, Inc. | 2004-06-14 |
| MINI L.E.D. OEM MODULE (K040808) | Satelec | 2004-04-28 |
Track EBZ automatically
Every clearance here is in the API, with alerts when new ones post.