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Osstell IDx
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 101000
by Osstell AB
Identity
- Trade Name
- Osstell IDx EUDAMEDOsstell IDx Instrument FDA UDI
- Generic Name
- Dental implant stability resonance frequency analysis unit FDA UDI
- Device Name
- Dental Implant Stability Measurement Control Unit EUDAMEDISQ Measurement Instrument FDA UDI
- Model / Reference
- 101000 EUDAMEDOsstell Osstell IDx Instrument FDA UDI
- Description
- ISQ Measurement Instrument FDA UDI
Identifiers
- Catalog Number
- 101000 FDA UDI
- Primary DI / UDI-DI
- D-OsstellIDxWE EUDAMED09010522000892 FDA UDI
- Basic UDI-DI
- B-OsstellIDxWE EUDAMED
- FDA Product Code
- EKX FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implant stability resonance frequency analysis unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Osstell IDx by Osstell AB — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142358 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-OsstellIDxWE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Osstell AB
- EUDAMED SRN
- SE-MF-000002162
Sources (3)
- EUDAMED 61c86e3f-a2d5-4622-bfd9-e967481f9fe2 61 fields · synced Jul 8, 2026
- FDA UDI bb2424c6-fee3-4a7d-821d-305a44058ced 34 fields · synced May 30, 2026
- FDA 510(k) K142358 1 fields · synced May 18, 2026