Identity
- Trade Name
- Intraoral Dental Digital Imaging Sensor FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- Size 1 FDA UDI
- Model / Reference
- Eagle S FDA UDI
- Description
- Size 1 FDA UDI
Identifiers
- Catalog Number
- 16000004135 FDA UDI
- Primary DI / UDI-DI
- 07899581340253 FDA UDI
- 510(k) Number
- K230732 FDA UDI
- FDA Product Code
- MUH FDA UDIEHD FDA UDIMQB FDA UDI
- GMDN Term
- Dental digital imaging sensor, intraoral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 FDA UDI892.1680 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
Category: Dental digital imaging sensor, intraoral
Intraoral Dental Digital Imaging Sensor by Alliage S/A Indústrias Médico Odontológica — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Dental digital imaging sensor, intraoral.
- DC-Air™ Intraoral Sensor — Athlos Oy · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- Schick — Dentsply International · Class II
- XIOS XG SELECT — SIRONA DENTAL, INC. · Class II
- CDR — SIRONA DENTAL, INC. · Class II
- XIOS XG SUPREME — SIRONA DENTAL, INC. · Class II
- SCHICK33 — SIRONA DENTAL, INC. · Class II
- XIOS XG WIFI — SIRONA DENTAL, INC. · Class II
Cleared under the same submission
K230732 also covers:
- EVOLVE SENSOR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- EVOLVE SENSOR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Intraoral Dental Digital Imaging Sensor — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Intraoral Dental Digital Imaging Sensor — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Intraoral Dental Digital Imaging Sensor — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Intraoral Dental Digital Imaging Sensor — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Intraoral Dental Digital Imaging Sensor — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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 (2)
- FDA UDI 101e8707-97d8-40b9-baba-f6a17fc7cfc1 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026