Ledex WL070+
by Dentmate Technology Co., Ltd.
510(k) K163605
Ledex WL070+ is a Class II device made by Dentmate Technology Co., Ltd., cleared under FDA 510(k) K163605 on 19 Jan 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163605 | Date19 Jan 2017 | StatusActive |
Official records
- FDA 510(k) database K163605
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBZ
- FDA applicant
- Dentmate Technology Co. , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6070
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K163605
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| LEDEX WL-070+ | WL-070+ | 04719873920730 | — | On the market |
| LEDEX WL-070+ | WL-070+ | 04719873920709 | — | On the market |
| LEDEX WL-070+ | WL-070+ | 04719873920693 | — | On the market |
| LEDEX WL-070+ | WL-070+ | 04719873920716 | — | On the market |
| LEDEX WL-070+ | WL-070+ | 04719873920686 | — | On the market |
| LEDEX WL-070+ | WL-070+ | 04719873920723 | — | On the market |
| LEDEX WL-070+ | WL-070+ | 04719873920679 | — | On the market |
| LEDEX WL-070+ (ORTHO) | WL-070+ (ORTHO) | 04719873921928 | — | On the market |
| LEDEX WL-070+ (ORTHO) | WL-070+ (ORTHO) | 04719873921263 | — | On the market |
| LEDEX WL-070+ (ORTHO) | WL-070+ (ORTHO) | 04719873921560 | — | On the market |
| LEDEX WL-070+ (ORTHO) | WL-070+ (ORTHO) | 04719873921584 | — | On the market |
| LEDEX WL-070+ (ORTHO) | WL-070+ (ORTHO) | 04719873921539 | — | On the market |
| LEDEX WL-070+ (ORTHO) | WL-070+ (ORTHO) | 04719873921935 | — | On the market |
| LEDEX WL-070+ (ORTHO) | WL-070+ (ORTHO) | 04719873921942 | — | On the market |
| LEDEX WL-070+ (ORTHO) | WL-070+ (ORTHO) | 04719873921911 | — | On the market |
| LEDEX WL-070+ (ORTHO) | WL-070+ (ORTHO) | 04719873921959 | — | On the market |
| LEDEX WL-070+ (ORTHO) | WL-070+ (ORTHO) | 04719873921553 | — | On the market |
| LEDEX WL-070+ (ORTHO) | WL-070+ (ORTHO) | 04719873921966 | — | On the market |
| LEDEX WL-070+ (ORTHO) | WL-070+ (ORTHO) | 04719873921577 | — | On the market |
| LEDEX WL-070+ (ORTHO) | WL-070+ (ORTHO) | 04719873921904 | — | On the market |
| LEDEX WL-070+ (ORTHO) | WL-070+ (ORTHO) | 04719873921546 | — | On the market |
Similar devices
Other devices filed under FDA product code EBZ (Activator, Ultraviolet, For Polymerization).
- D-LUX by DIADENT GROUP INTERNATIONAL
- VisCalor bulk 6063 by VOCO GmbH
- LED Curing Light, Model GT-1500 by Monitex Industrial Co., Ltd.
- ACTA by Satelec
- Contec Light by Dentaurum
- PlasmaCure BXE by Eele Laboratories, LLC
- LED Curing Light GT-2000 by Monitex Industrial Co., Ltd.
- Bonart ART-L5 LED Cordless Curing Light by BONART CO., LTD.
- Litex 680 by Dentamerica
- Elipar Freelight by Espe Dental AG