Ledex
by Dentmate Technology Co., Ltd. 2 variants
510(k) K131042
Ledex is a Class II device made by Dentmate Technology Co., Ltd., cleared under FDA 510(k) K131042 on 3 Oct 2013, 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 | NumberK131042 | Date3 Oct 2013 | StatusActive |
Official records
- FDA 510(k) database K131042
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- Withdrawn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 K131042
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-090 | WL-090 | 04719873920471 | On the market | |
| LEDEX WL-090+ | WL-090+ | 04719873920549 | On the market | |
| LEDX-PRO 90.10.2403 | 90.10.2403 / 90.10.2403 | 07908611204455 | On the market |
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