Osstell Classic Instrument
FDA UDIEUDAMEDClass I (US FDA UDI)
by Osstell AB
Identity
- Trade Name
- Osstell Classic EUDAMEDOsstell Classic Instrument FDA UDI
- Generic Name
- Dental implant stability resonance frequency analysis unit FDA UDI
- Device Name
- Osstell Instrument EUDAMEDISQ Measurement Instrument FDA UDI
- Model / Reference
- Osstell Beacon EUDAMED08086148 EUDAMEDOsstell Classic Instrument FDA UDI
- Description
- ISQ Measurement Instrument FDA UDI
Identifiers
- Catalog Number
- 08086148 FDA UDI
- Primary DI / UDI-DI
- 09010522002636 EUDAMEDFDA UDI
- Basic UDI-DI
- 9010522Beacon1C5 EUDAMED
- Direct Marketing DI
- 09010522002636 EUDAMED
- 510(k) Number
- K181888 FDA UDI
- 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 I EUDAMEDFDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant stability resonance frequency analysis unit
Osstell Classic Instrument by Osstell AB — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K181888 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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 1e6728d3-834b-4b13-830e-0983f50d2733 35 fields · synced Jul 8, 2026
- EUDAMED e7e2bdbd-7287-42f7-8391-0916e54bde81 61 fields · synced Jul 8, 2026