Identity
- Trade Name
- X-MIND trium FDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- X-MIND trium PAN version including one PAN sensor, with control panel on the left side including one removable ceph sensor configurated for installation of ceph arm on the right FDA UDI
- Model / Reference
- XMT PAN L CEPH READY R FDA UDI
- Description
- X-MIND trium PAN version including one PAN sensor, with control panel on the left side including one removable ceph sensor configurated for installation of ceph arm on the right FDA UDI
Identifiers
- Catalog Number
- W0900008 FDA UDI
- Primary DI / UDI-DI
- D804W09000080 FDA UDI
- FDA Product Code
- MUH FDA UDIOAS FDA UDI
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 FDA UDI892.1750 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
X-MIND trium by De Götzen Srl — 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
- De Götzen Srl
Sources (1)
- FDA UDI 29385e2c-d6c3-4fa8-818e-db4e309ffd28 37 fields · synced May 30, 2026