Ledex Wl-070+ (Ortho)
by Dentmate Technology Co., Ltd. 14 variants
Ledex Wl-070+ (Ortho) is a Class II device made by Dentmate Technology Co., Ltd., cleared under FDA 510(k) K163605 on 19 Jan 2017 and listed in FDA GUDID since 16 Jul 2019 (UDI-DI 04719873921966), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04719873921966 | Date16 Jul 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163605 | Date19 Jan 2017 | StatusActive |
Official records
- AccessGUDID record 04719873921966
- FDA 510(k) database K163605
Across registries
- FDA 510(k) K163605 decided 19 Jan 2017 Active
- FDA GUDID UDI-DI 04719873921966 listed 16 Jul 2019 Listed
Timeline
- Cleared FDA 510(k) K163605
- Listed FDA GUDID 04719873921966
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ledex
- Generic name
- Dental/surgical polymerization lamp
- Model / reference
- WL-070+ (ORTHO)
- Primary DI / UDI-DI
- 04719873921966
- 510(k) Number
- FDA product code
- EBZ
- GMDN term
- Dental/surgical polymerization lamp
- Device class
- Class II
- Regulation number
- 872.6070
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Dental/surgical polymerization lamp.