Identity
- Trade Name
- PREXION EVOLVE FDA UDI
- Generic Name
- Cone beam computed tomography system, head/neck FDA UDI
- Device Name
- Panoramic with Cephalostat (2 sensor) FDA UDI
- Model / Reference
- AXR90 FDA UDI
- Description
- Panoramic with Cephalostat (2 sensor) FDA UDI
Identifiers
- Catalog Number
- 16000004489 FDA UDI
- Primary DI / UDI-DI
- 07899581345005 FDA UDI
- 510(k) Number
- K223816 FDA UDI
- FDA Product Code
- OAS FDA UDI
- GMDN Term
- Cone beam computed tomography system, head/neck 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Cone beam computed tomography system, head/neck
Prexion Evolve 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
K223816 also covers:
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
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 a309d0df-616e-420a-a850-56365329982f 36 fields · synced Jun 9, 2026