Identity
- Trade Name
- Kavo 3D eXam+™ imaging system FDA UDI
- Generic Name
- Cone beam computed tomography system, head/neck FDA UDI
- Model / Reference
- 0.830.8000 FDA UDI
Identifiers
- Catalog Number
- 08308000 FDA UDI
- Primary DI / UDI-DI
- EKAV083080000 FDA UDI
- 510(k) Number
- K061284 FDA UDI
- FDA Product Code
- MUH FDA UDI
- GMDN Term
- Cone beam computed tomography system, head/neck FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Commercial Distribution
- Not 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
Kavo 3D eXam+™ imaging system by Dental Imaging Technologies Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dental Imaging Technologies Corporation
Sources (1)
- FDA UDI f9108740-9346-4bd1-9a59-fa80f202ab34 37 fields · synced Jun 9, 2026