DIO IDx Instrument Osstell DIO IDx Instrument
by Osstell AB
DIO IDx Instrument Osstell DIO IDx Instrument (100501) is a medical device (FDA Class I; FDA product code EKX, Handpiece, Direct Drive, Ac-Powered) made by Osstell AB, registered in EUDAMED and listed in FDA GUDID since 1 Nov 2022 (UDI-DI 09010522001141), active as of 23 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number09010522001141 | Date1 Nov 2022 | StatusListed |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Official records
- EUDAMED public site
- AccessGUDID record 09010522001141
Across registries
- EUDAMED Active
- FDA GUDID UDI-DI 09010522001141 listed 1 Nov 2022 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- DIO IDx Instrument
- Generic name
- Dental implant stability resonance frequency analysis unit
- Model / Ref / Catalog
- Osstell DIO IDx Instrument, 100501
- Primary DI / UDI-DI
- 09010522001141
- FDA product code
- EKX
- GMDN term
- Dental implant stability resonance frequency analysis unit
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution