Product code EBZ
- Device name
- Activator, Ultraviolet, For Polymerization
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.6070
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253461 | Demi Pro | Meta Systems Co., Ltd. | 2025-10-14 |
| K242386 | Bluemoon | Genoss Co., Ltd. | 2025-05-05 |
| K243921 | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | 2025-04-11 |
| K250009 | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited | 2025-04-10 |
| K241238 | LOOP™ LED Curing Light System (CLK01) | Garrison Dental Solutions, LLC | 2024-08-01 |
| K223414 | Curing Light, Model: MaxCure 9 | Guilin Refine Medical Instrument Co., Ltd. | 2023-11-15 |
| K233518 | BASE290 LED Curing Light | Handpiece Headquarters | 2023-11-02 |
| K223507 | CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) | Good Doctors Co., Ltd. | 2023-08-04 |
| K223142 | Coltolux Comfort LED Curing Light | Dent4you AG | 2022-12-22 |
| K220826 | LED Curing Light | Foshan Coxo Medical Instrument Co., Ltd. | 2022-12-08 |
| K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | 2022-11-23 |
| K221194 | LEDEX | Dentmate Technology Co. , Ltd. | 2022-09-16 |
| K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | 2022-02-22 |
| K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | 2021-03-01 |
| K200775 | LOOP LED Curing Light System | Garrison Dental Solutions, LLC | 2020-08-14 |
| K200809 | D-LUX+ | DiaDent Group International | 2020-08-07 |
| K192233 | LED Curing Light | Foshan Cicada Dental Instrument Co, Ltd. | 2020-02-13 |
| K191221 | Cybird LED Curing Light | Dxm Co., Ltd. | 2020-01-10 |
| K192009 | LED Curing Light | Ezgo Group, Inc. | 2020-01-09 |
| K191865 | SmartLite Pro Modular LED Curing Light | Dentsply Sirona | 2019-11-20 |
| K190272 | Bluephase PowerCure | Ivoclar Vivadent, AG | 2019-07-03 |
| K190627 | VALO Grand Corded | Ultradent Products, Inc. | 2019-04-29 |
| K180065 | FUSION Plus Curing Light | Dentlight, Inc. | 2019-04-19 |
| K181597 | Le'Pen | Kmihh, Ltd. | 2019-04-01 |
| K173157 | Dr's Light2 | Good Doctors Co., Ltd. | 2018-05-29 |
| K173876 | Cybird LED Curing Light | Dxm Co., Ltd. | 2018-01-24 |
| K161855 | LED Curing Light | Monitex Industrial Co., Ltd. | 2017-11-27 |
| K172426 | Clear Blue Digi LED Curing Light | Promident, LLC | 2017-08-16 |
| K170529 | Delight, Delight ortho, B&Lite S | Dentall Co., Ltd. | 2017-08-08 |
| K163064 | Demi Ultra | Kerr Corporation | 2017-07-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800017901640 | Cybird | DXM CO., LTD | 2026-04-21 |
| 07615208476217 | Bluephase EasyCure | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2024-09-25 |
| 07615208458787 | Bluephase PowerCure | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2024-03-25 |
| 07615208461206 | Bluephase G4 | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-06-14 |
| 07630392901468 | Coltolux Comfort | Dent4You AG | 2023-02-01 |
| 07630392901451 | Coltolux Comfort | Dent4You AG | 2023-02-01 |
| 07630392901444 | Coltolux Comfort | Dent4You AG | 2023-02-01 |
| 07630392901437 | Coltolux Comfort | Dent4You AG | 2023-02-01 |
| 07615208458251 | Bluephase G4 | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-11-21 |
| 07615208458558 | Bluephase G4 | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-11-21 |
| 07615208458503 | Bluephase G4 | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-11-21 |
| 07615208458459 | Bluephase G4 | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-11-21 |
| 07615208458404 | Bluephase G4 | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-11-21 |
| 07615208458350 | Bluephase G4 | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-11-21 |
| 07615208458305 | Bluephase G4 | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-11-21 |
| 07615208458206 | Bluephase G4 | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-11-21 |
| 07615208458749 | Bluephase PowerCure | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-11-21 |
| 08800025400227 | Guide-cap_Drs Light Claver | GOOD DOCTORS CO., LTD. | 2019-11-22 |
| 08800025400210 | Battery_Drs Light Claver | GOOD DOCTORS CO., LTD. | 2019-11-22 |
| 08800025400203 | Charger_Drs Light Claver | GOOD DOCTORS CO., LTD. | 2019-11-22 |
| 08800025400104 | Dr's Light2 | GOOD DOCTORS CO., LTD. | 2019-10-30 |
| 08800025400081 | Drs Light Claver | GOOD DOCTORS CO., LTD. | 2019-10-30 |
| 08800025400074 | Dr's Light | GOOD DOCTORS CO., LTD. | 2019-10-30 |
| 08806383540896 | D-Lux | DiaDent Group International | 2016-10-04 |
| J001702011085060 | Elipar™ Freelight™ | 3M Deutschland GmbH | 2016-09-24 |
| J001702011348820 | Elipar™ S10 | 3M Deutschland GmbH | 2016-09-24 |
| J001702011359390 | Elipar™ S10 | 3M Deutschland GmbH | 2016-09-24 |
| J001702011368950 | Elipar™ S10 | 3M Deutschland GmbH | 2016-09-24 |
| J001702011393450 | Elipar™ S10 | 3M Deutschland GmbH | 2016-09-24 |
| J001702011400040 | Paradigm™ | 3M Deutschland GmbH | 2016-09-24 |