Identity
- Trade Name
- ORTHOPHOS XG FDA UDI
- Generic Name
- Stationary panoramic dental x-ray system, digital FDA UDI
- Device Name
- ORTHOPHOS XG 5 / XG 5DS FDA UDI
- Model / Reference
- 6281229 FDA UDI
- Description
- ORTHOPHOS XG 5 / XG 5DS FDA UDI
Identifiers
- Primary DI / UDI-DI
- E27662812290 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Stationary panoramic dental x-ray system, digital 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
Orthophos Xg by Sirona Dental Systems GmbH — 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
- Sirona Dental Systems GmbH
Sources (1)
- FDA UDI 863a4173-3e87-401a-b378-5cfa50b91b5d 35 fields · synced Jun 1, 2026