Ledex
by Dentmate Technology Co., Ltd. 2 variants
510(k) K221194
Ledex is a Class II device made by Dentmate Technology Co., Ltd., cleared under FDA 510(k) K221194 on 16 Sep 2022, 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 | NumberK221194 | Date16 Sep 2022 | StatusActive |
Official records
- FDA 510(k) database K221194
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- Withdrawn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 K221194
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-120 | WL-120 | 04719873922444 | — | On the market |
| LEDEX WL-120 | WL-120 | 04719873922215 | — | On the market |
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