Rex 2
Rex 2 is a Class II device made by Dexcowin Co., Ltd., cleared under FDA 510(k) K140060 on 13 May 2014 and listed in FDA GUDID since 28 Feb 2017 (UDI-DI 08800000500041), active as of 20 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 | Number08800000500041 | Date28 Feb 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140060 | Date13 May 2014 | StatusActive |
Official records
- AccessGUDID record 08800000500041
- FDA 510(k) database K140060
Across registries
- FDA 510(k) K140060 decided 13 May 2014 Active
- FDA GUDID UDI-DI 08800000500041 listed 28 Feb 2017 Listed
Timeline
- Cleared FDA 510(k) K140060
- Listed FDA GUDID 08800000500041
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Dental digital imaging sensor, intraoral
- Model / reference
- Rex 2
- Primary DI / UDI-DI
- 08800000500041
- 510(k) Number
- FDA product code
- MUH
- GMDN term
- Dental digital imaging sensor, intraoral
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
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