Identity
- Trade Name
- Gendex CB-500™ HD imaging system FDA UDI
- Generic Name
- Cone beam computed tomography system, head/neck FDA UDI
- Device Name
- Dental CBCT FDA UDI
- Model / Reference
- 0.830.3000 FDA UDI
- Description
- Dental CBCT FDA UDI
Identifiers
- Catalog Number
- 08303000 FDA UDI
- Primary DI / UDI-DI
- EKAV083030000 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
Gendex CB-500™ HD 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 4cf2e94a-cba7-499e-b34c-b489afa20c25 37 fields · synced Jun 9, 2026