Identity
- Trade Name
- DIO IDx Instrument FDA UDI
- Generic Name
- Dental implant stability resonance frequency analysis unit FDA UDI
- Device Name
- ISQ Measurement Instrument FDA UDI
- Model / Reference
- Osstell DIO IDx Instrument FDA UDI
- Description
- ISQ Measurement Instrument FDA UDI
Identifiers
- Catalog Number
- 100501 FDA UDI
- Primary DI / UDI-DI
- 09010522001141 FDA UDI
- FDA Product Code
- EKX FDA UDI
- GMDN Term
- Dental implant stability resonance frequency analysis unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant stability resonance frequency analysis unit
DIO IDx Instrument by Osstell AB — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Osstell AB
Sources (2)
- FDA UDI 1b81a53e-65dc-4c20-b2e7-d13326f66d5a 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026