Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EBZ — Predicate Candidate Screening
214 FDA 510(k) clearances under this product code; the 50 most recent screened below.
65 daysmedian FDA review time
231 days90th percentile
214clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253131 | Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | 2026-06-18 | 266 | 0 |
| K253461 | Demi Pro | Meta Systems Co., Ltd. | 2025-10-14 | 7 | 0 |
| K242386 | Bluemoon | Genoss Co., Ltd. | 2025-05-05 | 266 | 0 |
| K243921 | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | 2025-04-11 | 112 | 0 |
| K250009 | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited | 2025-04-10 | 98 | 0 |
| K241238 | LOOP™ LED Curing Light System (CLK01) | Garrison Dental Solutions, LLC | 2024-08-01 | 90 | 0 |
| K223414 | Curing Light, Model: MaxCure 9 | Guilin Refine Medical Instrument Co., Ltd. | 2023-11-15 | 370 | 0 |
| K233518 | BASE290 LED Curing Light | Handpiece Headquarters | 2023-11-02 | 1 | 0 |
| K223507 | CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) | Good Doctors Co., Ltd. | 2023-08-04 | 255 | 0 |
| K223142 | Coltolux Comfort LED Curing Light | Dent4you AG | 2022-12-22 | 79 | 0 |
| K220826 | LED Curing Light | Foshan Coxo Medical Instrument Co., Ltd. | 2022-12-08 | 261 | 0 |
| K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | 2022-11-23 | 217 | 0 |
| K221194 | LEDEX | Dentmate Technology Co. , Ltd. | 2022-09-16 | 144 | 0 |
| K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | 2022-02-22 | 4 | 0 |
| K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | 2021-03-01 | 4 | 0 |
| K200775 | LOOP LED Curing Light System | Garrison Dental Solutions, LLC | 2020-08-14 | 142 | 0 |
| K200809 | D-LUX+ | DiaDent Group International | 2020-08-07 | 133 | 0 |
| K192233 | LED Curing Light | Foshan Cicada Dental Instrument Co, Ltd. | 2020-02-13 | 178 | 0 |
| K191221 | Cybird LED Curing Light | Dxm Co., Ltd. | 2020-01-10 | 248 | 0 |
| K192009 | LED Curing Light | Ezgo Group, Inc. | 2020-01-09 | 164 | 0 |
| K191865 | SmartLite Pro Modular LED Curing Light | Dentsply Sirona | 2019-11-20 | 131 | 0 |
| K190272 | Bluephase PowerCure | Ivoclar Vivadent, AG | 2019-07-03 | 145 | 0 |
| K190627 | VALO Grand Corded | Ultradent Products, Inc. | 2019-04-29 | 48 | 0 |
| K180065 | FUSION Plus Curing Light | Dentlight, Inc. | 2019-04-19 | 465 | 0 |
| K181597 | Le'Pen | Kmihh, Ltd. | 2019-04-01 | 287 | 0 |
| K173157 | Dr's Light2 | Good Doctors Co., Ltd. | 2018-05-29 | 242 | 0 |
| K173876 | Cybird LED Curing Light | Dxm Co., Ltd. | 2018-01-24 | 34 | 0 |
| K161855 | LED Curing Light | Monitex Industrial Co., Ltd. | 2017-11-27 | 509 | 0 |
| K172426 | Clear Blue Digi LED Curing Light | Promident, LLC | 2017-08-16 | 6 | 0 |
| K170529 | Delight, Delight ortho, B&Lite S | Dentall Co., Ltd. | 2017-08-08 | 167 | 0 |
| K163064 | Demi Ultra | Kerr Corporation | 2017-07-18 | 258 | 0 |
| K170101 | Valiant Curing Light | Inter-Med/Vista Dental Products | 2017-06-08 | 148 | 0 |
| K152192 | LED Curing Light | Monitex Industrial Co., Ltd. | 2017-04-07 | 611 | 0 |
| K163613 | Bluephase Style 20i | Ivoclar Vivadent, AG | 2017-04-04 | 103 | 0 |
| K163605 | LEDEX WL070+ | Dentmate Technology Co. , Ltd. | 2017-01-19 | 29 | 0 |
| K153514 | Premium Plus C01/C02 LED Curing Light | Premium Plus International Limited | 2016-08-22 | 259 | 0 |
| K160551 | VALO Grand | Ultradent Products, Inc. | 2016-07-13 | 135 | 0 |
| K153078 | LED Curing Light GT-2000 | Monitex Industrial Co., Ltd. | 2016-06-28 | 249 | 0 |
| K153018 | CELALUX 3 | Voco GmbH | 2016-06-23 | 252 | 0 |
| K150585 | Ascent 3D | CAO Group, Inc. | 2015-12-31 | 297 | 0 |
| K152936 | Sirius Max Dental Diode Curing Light | National Dental, Inc. | 2015-11-13 | 39 | 0 |
| K150205 | LED Curing Light | Monitex Industrial Co., Ltd. | 2015-08-24 | 207 | 0 |
| K140432 | HI-LIGHT, HI-LIGHT PLUS | Dentall Corporation | 2015-08-03 | 529 | 0 |
| K133040 | LED CURING LIGHT | Monitex Industrial Co., Ltd. | 2014-10-07 | 377 | 0 |
| K140281 | FLEXI-LUME LED SYSTEM | Epic Medical Concepts & Innovations | 2014-07-24 | 170 | 0 |
| K131906 | SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDI | Satelec - Acteon Group | 2014-04-11 | 289 | 0 |
| K131042 | LEDEX | Dentmate Technology Co. , Ltd. | 2013-10-03 | 171 | 0 |
| K130163 | D-LUX | DiaDent Group International | 2013-08-16 | 205 | 0 |
| K123468 | DEMI ULTRA | Kerr Corporation | 2013-03-20 | 131 | 0 |
| K121093 | D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 | Dxm Co., Ltd. | 2012-11-27 | 231 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda