Ledex, Model: Wl-070
by Dentmate Technology Co., Ltd.
510(k) K082408
Ledex, Model: Wl-070 is a Class II device made by Dentmate Technology Co., Ltd., cleared under FDA 510(k) K082408 on 3 Dec 2008, 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 | NumberK082408 | Date3 Dec 2008 | StatusActive |
Official records
- FDA 510(k) database K082408
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- Withdrawn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 K082408
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 | 04719873920143 | — | On the market |
| LEDEX WL-070 | WL-070 | 04719873920099 | — | On the market |
| LEDEX WL-070 | WL-070 | 04719873920150 | — | On the market |
| LEDEX WL-070 | WL-070 | 04719873920167 | — | On the market |
| LEDEX WL-070 | WL-070 | 04719873920082 | — | On the market |
| LEDEX WL-070 | WL-070 | 04719873920112 | — | On the market |
| LEDEX WL-070 | WL-070 | 04719873920129 | — | On the market |
| LEDEX WL-070 | WL-070 | 04719873920105 | — | On the market |
| LEDEX WL-070 | WL-070 | 04719873920136 | — | On the market |