Identity
- Trade Name
- MOBILE-X FDA UDI
- Generic Name
- Hand-held intraoral dental x-ray system, digital FDA UDI
- Device Name
- The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental X-ray source for producing diagnostic X-ray images using intra-oral image receptors Its use is in adults and pediatric subjects. FDA UDI
- Model / Reference
- T100 FDA UDI
- Description
- The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental X-ray source for producing diagnostic X-ray images using intra-oral image receptors Its use is in adults and pediatric subjects. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858475006153 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Hand-held intraoral dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hand-held intraoral dental x-ray system, digital
Mobile-X by Denterprise International, Inc. — 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
- Denterprise International, Inc.
Sources (1)
- FDA UDI eb3aa1f6-1599-4da2-9229-cb120b8008de 35 fields · synced May 30, 2026