StarX-1 9380000100
StarX-1 9380000100 is a Class II device made by Bluo Electronics SRL, cleared under FDA 510(k) K212103 on 30 Aug 2021 and listed in FDA GUDID since 2 Sep 2021 (UDI-DI E31593800001000), active as of 23 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 | NumberE31593800001000 | Date2 Sep 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212103 | Date30 Aug 2021 | StatusActive |
Official records
- FDA 510(k) database K212103
Across registries
- FDA 510(k) K212103 decided 30 Aug 2021 Active
- FDA GUDID UDI-DI E31593800001000 listed 2 Sep 2021 Listed
Timeline
- Cleared FDA 510(k) K212103
- Listed FDA GUDID E31593800001000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- StarX-1
- Generic name
- Dental digital imaging sensor, intraoral
- Model / reference
- 9380000100
- Primary DI / UDI-DI
- E31593800001000
- 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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