ADX4000W
510(k) K134055
ADX4000W is a Class II device made by Dexcowin Co., Ltd., cleared under FDA 510(k) K134055 on 9 May 2014, 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 | NumberK134055 | Date9 May 2014 | StatusActive |
Official records
- FDA 510(k) database K134055
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUH
- Device class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K134055
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 | |||
|---|---|---|---|---|
| ADX4000; iRay D4 ADX4000; ADX4000W | ADX4000; ADX4000W | 08800000500010 | — | On the market |
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