Identity
- Trade Name
- Osstell Beacon Instrument FDA UDI
- Generic Name
- Dental implant stability resonance frequency analysis unit FDA UDI
- Device Name
- ISQ Measurement Instrument FDA UDI
- Model / Reference
- Osstell Osstell Beacon Instrument FDA UDI
- Description
- ISQ Measurement Instrument FDA UDI
Identifiers
- Catalog Number
- 103000 FDA UDI
- Primary DI / UDI-DI
- 09010522000885 FDA UDI
- 510(k) Number
- K181888 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
Osstell Beacon 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
European Union Unknown
MDR
United States Pending data
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 6aae81c1-8d7c-4217-aa86-821ff75c6b8a 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026