Identity
- Trade Name
- DC-Air™ Intraoral Sensor FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- DC-Air™ Intraoral Sensor is intended for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure. The sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes. FDA UDI
- Model / Reference
- WIOS-S2 FDA UDI
- Description
- DC-Air™ Intraoral Sensor is intended for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure. The sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06429810587008 FDA UDI
- FDA Product Code
- MUH FDA UDI
- GMDN Term
- Dental digital imaging sensor, intraoral 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
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
No
FDA UDI
Category: Dental digital imaging sensor, intraoral
DC-Air™ Intraoral Sensor by Athlos Oy — 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
- Athlos Oy
Sources (1)
- FDA UDI 5a53ab25-a405-47c2-b4c8-856cb8b095bf 33 fields · synced Jun 8, 2026