Activator, Ultraviolet, For Polymerization
FDA product code EBZ · Class II (moderate risk) · 21 CFR 872.6070 · Dental
214510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Monitex Industrial Co., Ltd. 9
- Ivoclar Vivadent, Inc. 8
- Rolence Enterprise Co. , Ltd. 8
- Ultradent Products, Inc. 7
- Kerr Corporation 6
- Dentsply Intl. 5
- Dentmate Technology Co. , Ltd. 4
- 3M Company 4
- Satelec 4
- Good Doctors Co., Ltd. 4
- Dxm Co., Ltd. 4
- Apoza Enterprise Co., Ltd. 4
- Rolence Ent., Inc. 4
- J. Morita USA, Inc. 4
- Sybron Dental Specialties, Inc. 3
- Kulzer, Inc. 3
- Coltene/Whaledent, Inc. 3
- Demetron Research Corp. 3
- Discus Dental, Inc. 3
- Bonart Co., Ltd. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253131 | Curing Light (M-Cure 6)EBZ · Traditional | Guangzhou Rebornendo Medical Instrument Co., Ltd. | 06/18/2026SE |
| K253461 | Demi ProEBZ · Traditional | Meta Systems Co., Ltd. | 10/14/2025SE |
| K242386 | BluemoonEBZ · Traditional | Genoss Co., Ltd. | 05/05/2025SE |
| K243921 | LED Curing Lights (DB686 HALO)EBZ · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 04/11/2025SE |
| K250009 | LED Curing Light (C01-X, C02-X)EBZ · Traditional | Premium Plus (Dongguan) Limited | 04/10/2025SE |
| K241238 | LOOP LED Curing Light System (CLK01)EBZ · Traditional | Garrison Dental Solutions, LLC | 08/01/2024SE |
| K223414 | Curing Light, Model: MaxCure 9EBZ · Traditional | Guilin Refine Medical Instrument Co., Ltd. | 11/15/2023SE |
| K233518 | BASE290 LED Curing LightEBZ · Traditional | Handpiece Headquarters | 11/02/2023SE |
| K223507 | CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE)EBZ · Traditional | Good Doctors Co., Ltd. | 08/04/2023SE |
| K223142 | Coltolux Comfort LED Curing LightEBZ · Traditional | Dent4you AG | 12/22/2022SE |
| K220826 | LED Curing LightEBZ · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 12/08/2022SE |
| K221152 | CuringPen Dental Curing LightEBZ · Traditional | Changzhou Sifary Medical Technology Co., Ltd. | 11/23/2022SE |
| K221194 | LedexEBZ · Abbreviated | Dentmate Technology Co. , Ltd. | 09/16/2022SE |
| K220471 | VALO X, VALO X Accessory LensesEBZ · Traditional | Ultradent Products, Inc. | 02/22/2022SE |
| K210550 | VALO Grand Corded and Accessory LensesEBZ · Traditional | Ultradent Products, Inc. | 03/01/2021SE |
| K200775 | LOOP LED Curing Light SystemEBZ · Traditional | Garrison Dental Solutions, LLC | 08/14/2020SE |
| K200809 | D-Lux+EBZ · Traditional | DiaDent Group International | 08/07/2020SE |
| K192233 | LED Curing LightEBZ · Traditional | Foshan Cicada Dental Instrument Co, Ltd. | 02/13/2020SE |
| K191221 | Cybird LED Curing LightEBZ · Special | Dxm Co., Ltd. | 01/10/2020SE |
| K192009 | LED Curing LightEBZ · Traditional | Ezgo Group, Inc. | 01/09/2020SE |
| K191865 | SmartLite Pro Modular LED Curing LightEBZ · Traditional | Dentsply Sirona | 11/20/2019SE |
| K190272 | Bluephase PowerCureEBZ · Traditional | Ivoclar Vivadent, AG | 07/03/2019SE |
| K190627 | VALO Grand CordedEBZ · Special | Ultradent Products, Inc. | 04/29/2019SE |
| K180065 | FUSION Plus Curing LightEBZ · Traditional | Dentlight, Inc. | 04/19/2019SE |
| K181597 | Le'PenEBZ · Traditional | Kmihh, Ltd. | 04/01/2019SE |
| K173157 | Dr's Light2EBZ · Traditional | Good Doctors Co., Ltd. | 05/29/2018SE |
| K173876 | Cybird LED Curing LightEBZ · Special | Dxm Co., Ltd. | 01/24/2018SE |
| K161855 | LED Curing LightEBZ · Traditional | Monitex Industrial Co., Ltd. | 11/27/2017SE |
| K172426 | Clear Blue Digi LED Curing LightEBZ · Traditional | Promident, LLC | 08/16/2017SE |
| K170529 | Delight, Delight ortho, B&Lite SEBZ · Traditional | Dentall Co., Ltd. | 08/08/2017SE |
| K163064 | Demi UltraEBZ · Special | Kerr Corporation | 07/18/2017SE |
| K170101 | Valiant Curing LightEBZ · Traditional | Inter-Med/Vista Dental Products | 06/08/2017SE |
| K152192 | LED Curing LightEBZ · Traditional | Monitex Industrial Co., Ltd. | 04/07/2017SE |
| K163613 | Bluephase Style 20iEBZ · Abbreviated | Ivoclar Vivadent, AG | 04/04/2017SE |
| K163605 | Ledex WL070+EBZ · Special | Dentmate Technology Co. , Ltd. | 01/19/2017SE |
| K153514 | Premium Plus C01/C02 LED Curing LightEBZ · Abbreviated | Premium Plus International Limited | 08/22/2016SE |
| K160551 | VALO GrandEBZ · Special | Ultradent Products, Inc. | 07/13/2016SE |
| K153078 | LED Curing Light GT-2000EBZ · Traditional | Monitex Industrial Co., Ltd. | 06/28/2016SE |
| K153018 | Celalux 3EBZ · Traditional | Voco GmbH | 06/23/2016SE |
| K150585 | Ascent 3DEBZ · Abbreviated | CAO Group, Inc. | 12/31/2015SE |
| K152936 | Sirius Max Dental Diode Curing LightEBZ · Traditional | National Dental, Inc. | 11/13/2015SE |
| K150205 | LED Curing LightEBZ · Traditional | Monitex Industrial Co., Ltd. | 08/24/2015SE |
| K140432 | Hi-Light, Hi-Light PlusEBZ · Traditional | Dentall Corporation | 08/03/2015SE |
| K133040 | LED Curing LightEBZ · Traditional | Monitex Industrial Co., Ltd. | 10/07/2014SE |
| K140281 | Flexi-Lume LED SystemEBZ · Abbreviated | Epic Medical Concepts & Innovations | 07/24/2014SE |
| K131906 | Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray Cord), Scanwave Pen…EBZ · Abbreviated | Satelec - Acteon Group | 04/11/2014SE |
| K131042 | LedexEBZ · Traditional | Dentmate Technology Co. , Ltd. | 10/03/2013SE |
| K130163 | D-LuxEBZ · Traditional | DiaDent Group International | 08/16/2013SE |
| K123468 | Demi UltraEBZ · Traditional | Kerr Corporation | 03/20/2013SE |
| K121093 | D1 LED Curing Light, Spec 3, Dentronix LED 3000EBZ · Abbreviated | Dxm Co., Ltd. | 11/27/2012SE |
| K110756 | Bluephase StyleEBZ · Traditional | Ivoclar Vivadent, Inc. | 08/29/2011SE |
| K110582 | Valo CordlessEBZ · Special | Ultradent Products, Inc. | 04/28/2011SE |
| K102621 | SolsticeEBZ · Traditional | Kerr Corporation | 01/28/2011SE |
| K093751 | CL-DC20, CL-DC21EBZ · Traditional | Good Doctors Co., Ltd. | 02/24/2010SE |
| K092951 | Starlight Pro and Siliverlight Dental Curing LightsEBZ · Traditional | Mectron S.P.A. | 12/07/2009SE |
| K091887 | LED Curing Light, Model GT-1500EBZ · Traditional | Monitex Industrial Co., Ltd. | 09/18/2009SE |
| K091020 | Bluephase 20IEBZ · Traditional | Ivoclar Vivadent, Inc. | 06/12/2009SE |
| K083647 | Valo, Model 5919EBZ · Special | Ultradent Products, Inc. | 01/23/2009SE |
| K082408 | Ledex, Model: WL-070EBZ · Traditional | Dentmate Technology Co. , Ltd. | 12/03/2008SE |
| K081287 | Sapphire Plasma Arc Dental Curing LightEBZ · Abbreviated | Den-Mat Holdings, LLC | 11/21/2008SE |
| K082971 | Bonart ART-L5 LED Cordless Curing LightEBZ · Traditional | Bonart Co., Ltd. | 11/13/2008SE |
| K080025 | Led.L, Led.M, Led.G, Led.BEBZ · Traditional | Guilin Woodpecker Medical Instrument Co., Ltd. | 03/19/2008SE |
| K080035 | LED Curing LightEBZ · Traditional | Monitex Industrial Co., Ltd. | 03/03/2008SE |
| K073518 | Flashlite Rebel*EBZ · Traditional | Discus Dental, Inc. | 12/20/2007SE |
| K072807 | I LightEBZ · Abbreviated | Dent'N CO | 11/21/2007SE |
| K072181 | Mini LED AutofocusEBZ · Traditional | Satelec | 09/19/2007SE |
| K071908 | Doctor's Light LED Dental Curing LightEBZ · Traditional | Good Doctors Co., Ltd. | 08/23/2007SE |
| K071722 | Deep BlueEBZ · Traditional | E.M.S Electro Medical Systems S.A | 08/10/2007SE |
| K071251 | DemiEBZ · Traditional | Kerr Corporation | 07/26/2007SE |
| K063659 | Easy Curing Pen-Style LED Curing LightEBZ · Traditional | Dent Corp. Research & Development | 04/30/2007SE |
| K070373 | Apoza LED Curing Light, Model E-Morlit, D-2000, Top 3W, Top 5WEBZ · Special | Apoza Enterprise Co., Ltd. | 03/02/2007SE |
| K063529 | Pencure, Model VL-7EBZ · Traditional | J. Morita USA, Inc. | 01/05/2007SE |
| K062289 | Bonart ART-L3 LED Curing LightEBZ · Traditional | Bonart Co., Ltd. | 01/03/2007SE |
| K063116 | Demetron A.2EBZ · Traditional | Sybron Dental Specialties | 12/05/2006SE |
| K063003 | AuroraEBZ · Traditional | Parkell, Inc. | 11/28/2006SE |
| K062735 | Tutu 7, Model IV-T22EBZ · Traditional | Invisible Technology Co., Ltd. | 10/27/2006SE |
| K061658 | Spirit, Model M, U; Docportmacro, Model M, U, LEBZ · Traditional | Dentall Corp. | 09/18/2006SE |
| K061695 | LED Prolux 770EBZ · Traditional | Peng Lim Enterprise Co., Ltd. | 09/14/2006SE |
| K061395 | Calset Composite HeaterEBZ · Traditional | Addent, Inc. | 06/23/2006SE |
| K061341 | Palmlight 10, Model 001-00030EBZ · Traditional | CAO Group, Inc. | 06/12/2006SE |
| K060646 | Blue Luxcer Curing Light, Models M-830, M-835 and M-855EBZ · Traditional | Monitex Industrial Co., Ltd. | 04/21/2006SE |
| K052122 | Bisco LEDEBZ · Traditional | Bisco, Inc. | 03/29/2006SE |
| K052349 | Avante LED Curing Unit, Model N44EBZ · Traditional | Pentron Clinical Technologies | 10/21/2005SE |
| K052593 | Fusion Curing LightEBZ · Traditional | Dentlight, Inc. | 09/28/2005SE |
| K051782 | Bluephase 16IEBZ · Traditional | Ivoclar Vivadent, Inc. | 09/20/2005SE |
| K051780 | Jetlite 5000EBZ · Traditional | J. Morita USA, Inc. | 07/28/2005SE |
| K051571 | Skylight LED Curing LightEBZ · Traditional | Dmetec.Co., Ltd. | 07/19/2005SE |
| K051545 | L.E. Demetron IIEBZ · Traditional | Kerr Corporation (Danbury) | 07/18/2005SE |
| K051203 | BluelexEBZ · Traditional | Monitex Industrial Co., Ltd. | 05/25/2005SE |
| K050059 | G-LightEBZ · Traditional | GC America, Inc. | 02/03/2005SE |
| K043530 | Dvi Curing LightEBZ · Traditional | Designs For Vision, Inc. | 01/25/2005SE |
| K043302 | Nova-PulseEBZ · Special | Nova Ranger, Inc. | 01/03/2005SE |
| K042888 | Demetron Ids Curing LightEBZ · Traditional | Kerr Corp. | 11/10/2004SE |
| K042196 | Savedent BlueEBZ · Traditional | Denfotex Light Systems, Ltd. | 11/01/2004SE |
| K042703 | Cybird LED Curing LightEBZ · Traditional | Dxm Co., Ltd. | 10/12/2004SE |
| K042199 | Translux Power BlueEBZ · Traditional | Heraeus Kulzer,GmbH | 09/08/2004SE |
| K041372 | Smartlite PS Pen-Style LED Curing LightEBZ · Traditional | Dentsply International | 06/24/2004SE |
| K041303 | LED Turbo-PenEBZ · Traditional | Apoza Enterprise Co., Ltd. | 06/18/2004SE |
| K040956 | Hilux Ledmax 3EBZ · Traditional | First Medical Infection Control Associates, Inc. | 06/14/2004SE |
| K040808 | Mini L.E.D. Oem ModuleEBZ · Traditional | Satelec | 04/28/2004SE |
| K040614 | Bluewand LED Dental Curing Wand SystemEBZ · Traditional | J.L. Blosser, Inc. | 04/07/2004SE |
| K040618 | LED TurboEBZ · Traditional | Apoza Enterprise Co., Ltd. | 03/25/2004SE |
| K040551 | Coltolux LED Curing LightEBZ · Traditional | Coltene/Whaledent, Inc. | 03/15/2004SE |
| K033697 | Power LEDEBZ · Traditional | Dental Products of USA, Inc. | 02/27/2004SE |
| K033795 | Plasmacure BxeEBZ · Traditional | Eele Laboratories, LLC | 12/19/2003SE |
| K033520 | BluephaseEBZ · Traditional | Ivoclar Vivadent, Inc. | 12/05/2003SE |
| K033201 | LA500 Blue LightEBZ · Traditional | Apoza Enterprise Co., Ltd. | 12/02/2003SE |
| K032099 | Swiss Master LightEBZ · Traditional | (Ems Sa) Electro Medical Systems | 10/27/2003SE |
| K032465 | Mini L.E.D., Model: Mini L.E.D., Model Smartlite MiniEBZ · Traditional | Satelec | 10/21/2003SE |
| K031615 | Sled Curing Light SystemEBZ · Traditional | Dentsply International | 07/21/2003SE |
| K030811 | Cool CureEBZ · Traditional | Samm, Inc. | 06/10/2003SE |
| K030641 | Contec LightEBZ · Traditional | Dentaurum | 06/10/2003SE |
| K030568 | RadiiEBZ · Traditional | Southern Dental Industries, Inc. | 04/24/2003SE |
| K024374 | Rmo Plasma Curing LightEBZ · Traditional | Lokki Lasers Medicaux | 03/10/2003SE |
| K023748 | Flash-Lite II LED Dental Curing LightEBZ · Traditional | Discus Dental, Inc. | 01/17/2003SE |
| K023721 | Bonart ART-L2 Light Curing UnitEBZ · Traditional | Bonart Co., Ltd. | 01/10/2003SE |
| K023652 | Remecure Model CL 15EEBZ · Traditional | Remedent NV | 01/09/2003SE |
| K023545 | Ultra-Lite 200E Light Cure UnitEBZ · Traditional | Rolence Ent., Inc. | 12/30/2002SE |
| K022862 | Transcure, Model 2910EBZ · Traditional | Kinetic Instruments, Inc. | 10/18/2002SE |
| K022265 | Light TipEBZ · Traditional | Svenska Dental Instruments AB | 10/02/2002SE |
| K020057 | PalmlightEBZ · Traditional | CAO Group, Inc. | 08/27/2002SE |
| K022184 | Flash-Lite LED Dental Curing LightEBZ · Traditional | Discus Dental, Inc. | 08/20/2002SE |
| K021797 | L.E.DemetronEBZ · Traditional | Sybron Dental Specialties, Inc. | 06/27/2002SE |
| K020884 | Excellite Light Cure UnitEBZ · Traditional | Rolence Ent., Inc. | 06/12/2002SE |
| K020877 | Excellite Turbo Light Cure UnitEBZ · Traditional | Rolence Ent., Inc. | 06/12/2002SE |
| K020874 | Ultra-Lite 5 Turbo Light Cure UnitEBZ · Traditional | Rolence Ent., Inc. | 06/12/2002SE |
| K021374 | Toesco Aqua Blue LED Light Curing DeviceEBZ · Traditional | Toei Electric Co., Ltd. | 05/30/2002SE |
| K020267 | Optilux Curing LightsEBZ · Traditional | Sybron Dental Specialties, Inc. | 03/29/2002SE |
| K020091 | Optilux 501EBZ · Traditional | Kerr Corporation (Danbury) | 03/21/2002SE |
| K014179 | Demetron LCEBZ · Traditional | Kerr Corp. | 02/04/2002SE |
| K020171 | COOLBLU2 Dental Resin Curing DeviceEBZ · Special | Dental Systems.Com, Inc. | 01/29/2002SE |
| K013500 | Kavo Polylux IIEBZ · Traditional | Kavo America | 01/14/2002SE |
| K013277 | Astralis 7, Model 557545EBZ · Traditional | Ivoclar Vivadent, Inc. | 10/22/2001SE |
| K013275 | Astralis 10, Models # 559588, 561859EBZ · Traditional | Ivoclar Vivadent, Inc. | 10/19/2001SE |
| K012946 | Sunliteled Model #2810EBZ · Traditional | Kinetic Instruments, Inc. | 10/02/2001SE |
| K012341 | Translux EnergyEBZ · Traditional | Heraeus Kulzer, Inc. | 08/30/2001SE |
| K012134 | GC E-LightEBZ · Traditional | GC America, Inc. | 08/07/2001SE |
| K011154 | Elipar FreelightEBZ · Traditional | Espe Dental AG | 05/16/2001SE |
| K010133 | VersaluxEBZ · Traditional | Centrix, Inc. | 04/05/2001SE |
| K003383 | PalmlightEBZ · Traditional | Ultradent Products, Inc. | 02/06/2001SE |
| K003683 | Avante CurelightEBZ · Traditional | Jeneric/Pentron, Inc. | 01/11/2001SE |
| K002925 | Coolblu Curing LightEBZ · Traditional | Dental Systems.Com, Inc. | 12/20/2000SE |
| K002991 | Zap Dual Curing LightEBZ · Traditional | Soft-Core Texas, Inc. | 11/28/2000SE |
| K002566 | Lumalite Cure Light, Model 2100EBZ · Traditional | Lumalite, Inc. | 10/19/2000SE |
| K001719 | Q-Lux Plasma 100 Light Cure UnitEBZ · Traditional | Rolence Enterprise Co. , Ltd. | 10/10/2000SE |
| K000078 | Jetlite 4000EBZ · Traditional | J. Morita USA, Inc. | 05/15/2000SE |
| K000426 | Vip- Variable Intensity PolymerizerEBZ · Traditional | Bisco, Inc. | 04/12/2000SE |
| K000393 | Nova Cordless Curing LightEBZ · Traditional | Nova/Da Vinci Systems, Inc. | 03/27/2000SE |
| K994048 | Portable Light Curing UnitEBZ · Traditional | Gregory S. Jacob, D.D.S. | 01/13/2000SE |
| K994028 | Flipo Xenon Curing LightEBZ · Traditional | Lokki | 01/12/2000SE |
| K993223 | Rapicure 200 (Curing and Whitening Light)EBZ · Traditional | Mediphotonix, LC | 11/01/1999SE |
| K992728 | Spring Powerlite 2000EBZ · Traditional | Spring Health Products, Inc. | 09/29/1999SE |
| K992357 | Easy-Cure (Curing and Whitening Light)EBZ · Traditional | Ics of North America, Inc. | 08/30/1999SE |
| K992236 | Lysta LC Compacta Curing Light, Models LC 2500 Compacta, LC 4000 Compacta, LC 6000…EBZ · Traditional | Lysta A/S | 08/27/1999SE |
| K991865 | Q-Lite 75 Light Cure UnitEBZ · Traditional | Rolence Enterprise Co. , Ltd. | 07/20/1999SE |
| K991863 | Cute-Lite I Light Cure UnitEBZ · Traditional | Rolence Enterprise Co. , Ltd. | 07/19/1999SE |
| K991138 | Lysta LC Curing Light, Model LC 2500C/BAEBZ · Traditional | Lysta A/S | 04/23/1999SE |
| K984247 | Elipar TrilightEBZ · Traditional | Espe Dental AG | 02/25/1999SE |
| K982615 | Airdent Radiance Curing LightEBZ · Traditional | Air Techniques, Inc. | 08/24/1998SE |
| K974369 | Apollo 9500EBZ · Traditional | Ion Laser Technology | 01/06/1998SE |
| K972355 | 3M Aurora SystemEBZ · Traditional | 3M Company | 08/29/1997SE |
| K972006 | Acta Oem ModuleEBZ · Traditional | Interactive Consulting, Inc. | 07/10/1997SE |
| K970506 | Hilux 200,250,275,300,350,500 Dental Curing LightEBZ · Traditional | Benlioglu Dental Ithalat, Inc. | 06/04/1997SE |
| K964524 | Ilt Argon HPEBZ · Traditional | Ion Laser Technology | 03/18/1997SE |
| K963110 | JetliteEBZ · Traditional | J. Morita USA, Inc. | 10/24/1996SE |
| K961735 | ActaEBZ · Traditional | Satelec | 07/31/1996SE |
| K960364 | CU-200 Light Cure UnitEBZ · Traditional | Rolence Enterprise Co. , Ltd. | 04/15/1996SE |
| K960351 | Q-Lux Light Cure UnitEBZ · Traditional | Rolence Enterprise Co. , Ltd. | 04/15/1996SE |
| K953898 | ACL-5500 Precision Curing Unit (Pcu)EBZ · Traditional | Ion Laser Technology | 02/15/1996SE |
| K955763 | Optilux 400EBZ · Traditional | Demetron Research Corp. | 01/04/1996SE |
| K955759 | Litex 680EBZ · Traditional | Dentamerica | 01/02/1996SE |
| K954061 | Poly-Lite Model 1000EBZ · Traditional | Pro-Den Systems, Inc. | 09/21/1995SE |
| K952423 | CU-100RLC Light Cure Unit, Document NO.A715676EBZ · Traditional | Rolence Enterprise Co. , Ltd. | 06/22/1995SE |
| K951465 | Sunlite 1275EBZ · Traditional | Fen Dental Mfg., Inc. | 05/31/1995SE |
| K950106 | Coltolux Light MeterEBZ · Traditional | Coltene/Whaledent, Inc. | 05/24/1995SE |
| K945698 | Coltolux 3, Coltolux 4EBZ · Traditional | Coltene/Whaledent, Inc. | 05/24/1995SE |
| K951425 | Spectrum Curing Light Polymerization UnitEBZ · Traditional | Dentsply Intl. | 05/05/1995SE |
| K942199 | CU-100R Light Cure Unit, Document No. A715676EBZ · Traditional | Rolence Enterprise Co. , Ltd. | 06/02/1994SE |
| K942198 | CU-80 Light Cure Unit, Document No. A715676EBZ · Traditional | Rolence Enterprise Co. , Ltd. | 05/27/1994SE |
| K934746 | 3M Curing Light XL1500EBZ · Traditional | 3M Company | 01/06/1994SE |
| K930086 | Ortholux XTEBZ · Traditional | 3M Company | 04/23/1993SE |
| K924812 | 3M Curing Light XL 3000EBZ · Traditional | 3M Company | 11/25/1992SE |
| K912994 | Compalux Stroboscopic Light Polymerization DeviceEBZ · Traditional | Wilde-USA, Inc. | 12/23/1991SE |
| K913980 | HelioluxEBZ · Traditional | Ivoclar North America, Inc. | 12/16/1991SE |
| K910068 | SpectramatEBZ · Traditional | Ivoclar North America, Inc. | 03/15/1991SE |
| K905543 | Lares Apollo Cs/Cp/CEBZ · Traditional | Lares Research, Inc. | 03/11/1991SE |
| K901908 | Heliolux Visible Curing LightEBZ · Traditional | Ivoclar North America, Inc. | 07/13/1990SE |
| K900135 | CU-75 Visible Light-Curing UnitEBZ · Traditional | Kab Gloves Unltd. | 05/07/1990SE |
| K895085 | Walklite Protable Re-Chargeable Curing LightEBZ · Traditional | Lustgarten Multi-Tech International, Inc. | 04/02/1990SE |
| K892517 | Tulux-FilterEBZ · Traditional | Espe GmbH (Us) | 08/21/1989SE |
| K892456 | Kulzer Translux EcEBZ · Traditional | Kulzer, Inc. | 06/14/1989SE |
| K884222 | Curing Light CoverEBZ · Traditional | Steri-Shield Products, Inc. | 03/17/1989SE |
| K882145 | Photo-Curing LightEBZ · Traditional | Dentsply Intl. | 09/06/1988SE |
| K880392 | Ortholux Visible Light Curing UnitEBZ · Traditional | Unitek Corp. | 04/07/1988SE |
| K854696 | Op II Visible Light Curing SystemEBZ · Traditional | Almore Intl., Inc. | 03/26/1986SE |
| K851915 | Curing LightEBZ · Traditional | Technology, Inc. | 07/09/1985SE |
| K844351 | Opti-LiteEBZ · Traditional | Innovators, Inc. | 12/21/1984SE |
| K844325 | Coe-Lite Polymerization UnitEBZ · Traditional | Coe Laboratories, Inc. | 12/11/1984SE |
| K843823 | Translux CLEBZ · Traditional | Kulzer, Inc. | 12/04/1984SE |
| K832320 | Prisma IIIEBZ · Traditional | Dentsply Intl. | 08/31/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0746-2022 Class II | PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial…The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications. | Envisiontec US Llc | 01/20/2022Open, Classified |
| Z-0797-2019 Class II | Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing…Tip of the curing light was too hot causing a heat sensation in the patients. | Handpiece Headquarters | 04/04/2018Open, Classified |
| Z-1740-2014 Class II | bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin…A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of… | Ivoclar Vivadent, Inc. | 04/14/2014Terminated |
| Z-1505-2012 | DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable…Disposa-Shield Disposable Curing Shield is recalled due to lacking 510K, PMA or IDE, and inadequate quality… | O'Ryan Industries Inc | 04/23/2012Terminated |