Owandy Radiology OWANDY OPTEO SIZE 1.5
Owandy Radiology OWANDY OPTEO SIZE 1.5 (9458100150) is a Class II device made by Owandy Radiology, cleared under FDA 510(k) K133271 on 28 Apr 2014 and listed in FDA GUDID since 15 May 2025 (UDI-DI 03760262650814), 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 | Number03760262650814 | Date15 May 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133271 | Date28 Apr 2014 | StatusActive |
Official records
- AccessGUDID record 03760262650814
- FDA 510(k) database K133271
Across registries
- FDA 510(k) K133271 decided 28 Apr 2014 Active
- FDA GUDID UDI-DI 03760262650814 listed 15 May 2025 Listed
Timeline
- Cleared FDA 510(k) K133271
- Listed FDA GUDID 03760262650814
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Owandy Radiology
- Generic name
- Dental digital imaging sensor, intraoral
- Model / Ref / Catalog
- OWANDY OPTEO SIZE 1.5, 9458100150
- Primary DI / UDI-DI
- 03760262650814
- 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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