Identity
- Trade Name
- PaX-i3D Smart FDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (Xmaru1404CF / Xmaru2301CF) FDA UDI
- Model / Reference
- PHT-30LFO FDA UDI
- Description
- Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (Xmaru1404CF / Xmaru2301CF) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016400014 FDA UDI
- FDA Product Code
- OAS FDA UDI
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 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: Stationary panoramic/tomographic dental x-ray system, digital
PaX-i3D Smart by Vatech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Vatech Co., Ltd.
Sources (1)
- FDA UDI fd217d02-23ed-4e92-bd1f-b55f9a569fcb 34 fields · synced May 30, 2026