Stellaris 3D 8468600000
Stellaris 3D 8468600000 is a Class II device made by Bluo Electronics SRL, cleared under FDA 510(k) K213579 on 2 Mar 2022 and listed in FDA GUDID since 29 Apr 2022 (UDI-DI E3158468600000), 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 | NumberE3158468600000 | Date29 Apr 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213579 | Date2 Mar 2022 | StatusActive |
Official records
- FDA 510(k) database K213579
Across registries
- FDA 510(k) K213579 decided 2 Mar 2022 Active
- FDA GUDID UDI-DI E3158468600000 listed 29 Apr 2022 Listed
Timeline
- Cleared FDA 510(k) K213579
- Listed FDA GUDID E3158468600000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Stellaris 3D
- Generic name
- Stationary panoramic/tomographic dental x-ray system, digital
- Model / reference
- 8468600000
- Primary DI / UDI-DI
- E3158468600000
- 510(k) Number
- FDA product code
- OAS
- GMDN term
- Stationary panoramic/tomographic dental x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
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