FDA Product Code
FDA Product Code EBZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.6070
510(k) Clearances — 214 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253131 | Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | 2026-06-18 | Traditional | PDF ↗ |
| K253461 | Demi Pro | Meta Systems Co., Ltd. | 2025-10-14 | Traditional | PDF ↗ |
| K242386 | Bluemoon | Genoss Co., Ltd. | 2025-05-05 | Traditional | PDF ↗ |
| K243921 | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | 2025-04-11 | Traditional | PDF ↗ |
| K250009 | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited | 2025-04-10 | Traditional | PDF ↗ |
| K241238 | LOOP LED Curing Light System (CLK01) | Garrison Dental Solutions, LLC | 2024-08-01 | Traditional | PDF ↗ |
| K223414 | Curing Light, Model: MaxCure 9 | Guilin Refine Medical Instrument Co., Ltd. | 2023-11-15 | Traditional | PDF ↗ |
| K233518 | BASE290 LED Curing Light | Handpiece Headquarters | 2023-11-02 | Traditional | PDF ↗ |
| K223507 | CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE) | Good Doctors Co., Ltd. | 2023-08-04 | Traditional | PDF ↗ |
| K223142 | Coltolux Comfort LED Curing Light | Dent4you AG | 2022-12-22 | Traditional | PDF ↗ |
| K220826 | LED Curing Light | Foshan Coxo Medical Instrument Co., Ltd. | 2022-12-08 | Traditional | PDF ↗ |
| K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | 2022-11-23 | Traditional | PDF ↗ |
| K221194 | LEDEX | Dentmate Technology Co. , Ltd. | 2022-09-16 | Abbreviated | PDF ↗ |
| K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | 2022-02-22 | Traditional | PDF ↗ |
| K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | 2021-03-01 | Traditional | PDF ↗ |
| K200775 | LOOP LED Curing Light System | Garrison Dental Solutions, LLC | 2020-08-14 | Traditional | PDF ↗ |
| K200809 | D-LUX+ | DiaDent Group International | 2020-08-07 | Traditional | PDF ↗ |
| K192233 | LED Curing Light | Foshan Cicada Dental Instrument Co, Ltd. | 2020-02-13 | Traditional | PDF ↗ |
| K191221 | Cybird LED Curing Light | Dxm Co., Ltd. | 2020-01-10 | Special | PDF ↗ |
| K192009 | LED Curing Light | Ezgo Group, Inc. | 2020-01-09 | Traditional | PDF ↗ |
| K191865 | SmartLite Pro Modular LED Curing Light | Dentsply Sirona | 2019-11-20 | Traditional | PDF ↗ |
| K190272 | Bluephase PowerCure | Ivoclar Vivadent, AG | 2019-07-03 | Traditional | PDF ↗ |
| K190627 | VALO Grand Corded | Ultradent Products, Inc. | 2019-04-29 | Special | PDF ↗ |
| K180065 | FUSION Plus Curing Light | Dentlight, Inc. | 2019-04-19 | Traditional | PDF ↗ |
| K181597 | Le'Pen | Kmihh, Ltd. | 2019-04-01 | Traditional | PDF ↗ |
| K173157 | Dr's Light2 | Good Doctors Co., Ltd. | 2018-05-29 | Traditional | PDF ↗ |
| K173876 | Cybird LED Curing Light | Dxm Co., Ltd. | 2018-01-24 | Special | PDF ↗ |
| K161855 | LED Curing Light | Monitex Industrial Co., Ltd. | 2017-11-27 | Traditional | PDF ↗ |
| K172426 | Clear Blue Digi LED Curing Light | Promident, LLC | 2017-08-16 | Traditional | PDF ↗ |
| K170529 | Delight, Delight ortho, B&Lite S | Dentall Co., Ltd. | 2017-08-08 | Traditional | PDF ↗ |
| K163064 | Demi Ultra | Kerr Corporation | 2017-07-18 | Special | PDF ↗ |
| K170101 | Valiant Curing Light | Inter-Med/Vista Dental Products | 2017-06-08 | Traditional | PDF ↗ |
| K152192 | LED Curing Light | Monitex Industrial Co., Ltd. | 2017-04-07 | Traditional | PDF ↗ |
| K163613 | Bluephase Style 20i | Ivoclar Vivadent, AG | 2017-04-04 | Abbreviated | PDF ↗ |
| K163605 | LEDEX WL070+ | Dentmate Technology Co. , Ltd. | 2017-01-19 | Special | PDF ↗ |
| K153514 | Premium Plus C01/C02 LED Curing Light | Premium Plus International Limited | 2016-08-22 | Abbreviated | PDF ↗ |
| K160551 | VALO Grand | Ultradent Products, Inc. | 2016-07-13 | Special | PDF ↗ |
| K153078 | LED Curing Light GT-2000 | Monitex Industrial Co., Ltd. | 2016-06-28 | Traditional | PDF ↗ |
| K153018 | CELALUX 3 | Voco GmbH | 2016-06-23 | Traditional | PDF ↗ |
| K150585 | Ascent 3D | CAO Group, Inc. | 2015-12-31 | Abbreviated | PDF ↗ |
| K152936 | Sirius Max Dental Diode Curing Light | National Dental, Inc. | 2015-11-13 | Traditional | PDF ↗ |
| K150205 | LED Curing Light | Monitex Industrial Co., Ltd. | 2015-08-24 | Traditional | PDF ↗ |
| K140432 | HI-LIGHT, HI-LIGHT PLUS | Dentall Corporation | 2015-08-03 | Traditional | PDF ↗ |
| K133040 | LED CURING LIGHT | Monitex Industrial Co., Ltd. | 2014-10-07 | Traditional | PDF ↗ |
| K140281 | FLEXI-LUME LED SYSTEM | Epic Medical Concepts & Innovations | 2014-07-24 | Abbreviated | PDF ↗ |
| K131906 | SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE | Satelec - Acteon Group | 2014-04-11 | Abbreviated | PDF ↗ |
| K131042 | LEDEX | Dentmate Technology Co. , Ltd. | 2013-10-03 | Traditional | PDF ↗ |
| K130163 | D-LUX | DiaDent Group International | 2013-08-16 | Traditional | PDF ↗ |
| K123468 | DEMI ULTRA | Kerr Corporation | 2013-03-20 | Traditional | PDF ↗ |
| K121093 | D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 | Dxm Co., Ltd. | 2012-11-27 | Abbreviated | PDF ↗ |
| K110756 | BLUEPHASE STYLE | Ivoclar Vivadent, Inc. | 2011-08-29 | Traditional | PDF ↗ |
| K110582 | VALO CORDLESS | Ultradent Products, Inc. | 2011-04-28 | Special | PDF ↗ |
| K102621 | SOLSTICE | Kerr Corporation | 2011-01-28 | Traditional | PDF ↗ |
| K093751 | CL-DC20, CL-DC21 | Good Doctors Co., Ltd. | 2010-02-24 | Traditional | PDF ↗ |
| K092951 | STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS | Mectron S.P.A. | 2009-12-07 | Traditional | PDF ↗ |
| K091887 | LED CURING LIGHT, MODEL GT-1500 | Monitex Industrial Co., Ltd. | 2009-09-18 | Traditional | PDF ↗ |
| K091020 | BLUEPHASE 20I | Ivoclar Vivadent, Inc. | 2009-06-12 | Traditional | PDF ↗ |
| K083647 | VALO, MODEL 5919 | Ultradent Products, Inc. | 2009-01-23 | Special | PDF ↗ |
| K082408 | LEDEX, MODEL: WL-070 | Dentmate Technology Co. , Ltd. | 2008-12-03 | Traditional | PDF ↗ |
| K081287 | SAPPHIRE PLASMA ARC DENTAL CURING LIGHT | Den-Mat Holdings, LLC | 2008-11-21 | Abbreviated | PDF ↗ |
| K082971 | BONART ART-L5 LED CORDLESS CURING LIGHT | Bonart Co., Ltd. | 2008-11-13 | Traditional | PDF ↗ |
| K080025 | LED.L, LED.M, LED.G, LED.B | Guilin Woodpecker Medical Instrument Co., Ltd. | 2008-03-19 | Traditional | PDF ↗ |
| K080035 | LED CURING LIGHT | Monitex Industrial Co., Ltd. | 2008-03-03 | Traditional | PDF ↗ |
| K073518 | FLASHLITE REBEL* | Discus Dental, Inc. | 2007-12-20 | Traditional | PDF ↗ |
| K072807 | I LIGHT | Dent'N CO | 2007-11-21 | Abbreviated | PDF ↗ |
| K072181 | MINI LED AUTOFOCUS | Satelec | 2007-09-19 | Traditional | PDF ↗ |
| K071908 | DOCTOR'S LIGHT LED DENTAL CURING LIGHT | Good Doctors Co., Ltd. | 2007-08-23 | Traditional | PDF ↗ |
| K071722 | DEEP BLUE | E.M.S Electro Medical Systems S.A | 2007-08-10 | Traditional | PDF ↗ |
| K071251 | DEMI | Kerr Corporation | 2007-07-26 | Traditional | PDF ↗ |
| K063659 | EASY CURING PEN-STYLE LED CURING LIGHT | Dent Corp. Research & Development | 2007-04-30 | Traditional | PDF ↗ |
| K070373 | APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W | Apoza Enterprise Co., Ltd. | 2007-03-02 | Special | PDF ↗ |
| K063529 | PENCURE, MODEL VL-7 | J. Morita USA, Inc. | 2007-01-05 | Traditional | PDF ↗ |
| K062289 | BONART ART-L3 LED CURING LIGHT | Bonart Co., Ltd. | 2007-01-03 | Traditional | PDF ↗ |
| K063116 | DEMETRON A.2 | Sybron Dental Specialties | 2006-12-05 | Traditional | PDF ↗ |
| K063003 | AURORA | Parkell, Inc. | 2006-11-28 | Traditional | PDF ↗ |
| K062735 | TUTU 7, MODEL IV-T22 | Invisible Technology Co., Ltd. | 2006-10-27 | Traditional | PDF ↗ |
| K061658 | SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L | Dentall Corp. | 2006-09-18 | Traditional | PDF ↗ |
| K061695 | LED PROLUX 770 | Peng Lim Enterprise Co., Ltd. | 2006-09-14 | Traditional | PDF ↗ |
| K061395 | CALSET COMPOSITE HEATER | Addent, Inc. | 2006-06-23 | Traditional | PDF ↗ |
| K061341 | PALMLIGHT 10, MODEL 001-00030 | CAO Group, Inc. | 2006-06-12 | Traditional | PDF ↗ |
| K060646 | BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 | Monitex Industrial Co., Ltd. | 2006-04-21 | Traditional | PDF ↗ |
| K052122 | BISCO LED | Bisco, Inc. | 2006-03-29 | Traditional | PDF ↗ |
| K052349 | AVANTE LED CURING UNIT, MODEL N44 | Pentron Clinical Technologies | 2005-10-21 | Traditional | PDF ↗ |
| K052593 | FUSION CURING LIGHT | Dentlight, Inc. | 2005-09-28 | Traditional | PDF ↗ |
| K051782 | BLUEPHASE 16I | Ivoclar Vivadent, Inc. | 2005-09-20 | Traditional | PDF ↗ |
| K051780 | JETLITE 5000 | J. Morita USA, Inc. | 2005-07-28 | Traditional | PDF ↗ |
| K051571 | SKYLIGHT LED CURING LIGHT | Dmetec.Co., Ltd. | 2005-07-19 | Traditional | PDF ↗ |
| K051545 | L.E. DEMETRON II | Kerr Corporation (Danbury) | 2005-07-18 | Traditional | PDF ↗ |
| K051203 | BLUELEX | Monitex Industrial Co., Ltd. | 2005-05-25 | Traditional | PDF ↗ |
| K050059 | G-LIGHT | GC America, Inc. | 2005-02-03 | Traditional | PDF ↗ |
| K043530 | DVI CURING LIGHT | Designs For Vision, Inc. | 2005-01-25 | Traditional | PDF ↗ |
| K043302 | NOVA-PULSE | Nova Ranger, Inc. | 2005-01-03 | Special | PDF ↗ |
| K042888 | DEMETRON IDS CURING LIGHT | Kerr Corp. | 2004-11-10 | Traditional | PDF ↗ |
| K042196 | SAVEDENT BLUE | Denfotex Light Systems, Ltd. | 2004-11-01 | Traditional | PDF ↗ |
| K042703 | CYBIRD LED CURING LIGHT | Dxm Co., Ltd. | 2004-10-12 | Traditional | PDF ↗ |
| K042199 | TRANSLUX POWER BLUE | Heraeus Kulzer,GmbH | 2004-09-08 | Traditional | PDF ↗ |
| K041372 | SMARTLITE PS PEN-STYLE LED CURING LIGHT | Dentsply International | 2004-06-24 | Traditional | PDF ↗ |
| K041303 | LED TURBO-PEN | Apoza Enterprise Co., Ltd. | 2004-06-18 | Traditional | PDF ↗ |
| K040956 | HILUX LEDMAX 3 | First Medical Infection Control Associates, Inc. | 2004-06-14 | Traditional | PDF ↗ |
| K040808 | MINI L.E.D. OEM MODULE | Satelec | 2004-04-28 | Traditional | PDF ↗ |
Product code EBZ · Class II · Dental. Data: openFDA.