Identity
- Trade Name
- EAGLE X-RAY FDA UDI
- Generic Name
- Hand-held intraoral dental x-ray system, digital FDA UDI
- Model / Reference
- AXR65 S FDA UDI
Identifiers
- Catalog Number
- 16000004375 FDA UDI
- Primary DI / UDI-DI
- 07899581340703 FDA UDI
- 510(k) Number
- K233395 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hand-held intraoral dental x-ray system, digital
Eagle X-Ray by Alliage S/A Indústrias Médico Odontológica — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K233395 also covers:
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
- Alliage S/A Indústrias Médico Odontológica
Sources (1)
- FDA UDI c163029c-dff3-4d70-9516-9bc1cf9f4697 35 fields · synced Jun 9, 2026