Star-X
Star-X is a Class II device made by Hdx Will Corp., cleared under FDA 510(k) K190357 on 15 Mar 2019 and listed in FDA GUDID since 28 Apr 2021 (UDI-DI 08800005200151), active as of 21 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 | Number08800005200151 | Date28 Apr 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190357 | Date15 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 08800005200151
- FDA 510(k) database K190357
Across registries
- FDA 510(k) K190357 decided 15 Mar 2019 Active
- FDA GUDID UDI-DI 08800005200151 listed 28 Apr 2021 Listed
Timeline
- Cleared FDA 510(k) K190357
- Listed FDA GUDID 08800005200151
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Stationary intraoral dental x-ray system, digital
- Model / reference
- STAR-X
- Primary DI / UDI-DI
- 08800005200151
- 510(k) Number
- FDA product code
- EHD
- GMDN term
- Stationary intraoral dental x-ray system, digital
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
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