Identity
- Trade Name
- HDI2000 FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- The HDI 2000 is a solid state x-ray imager designed for dental radiographic applications. The HDI 2000 provides digital image capture for conventional film/screen radiographic dental examinations. The device is used to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port FDA UDI
- Model / Reference
- HDI2000 FDA UDI
- Description
- The HDI 2000 is a solid state x-ray imager designed for dental radiographic applications. The HDI 2000 provides digital image capture for conventional film/screen radiographic dental examinations. The device is used to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port FDA UDI
Identifiers
- Catalog Number
- 2.0 FDA UDI
- Primary DI / UDI-DI
- 08800018600139 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Dental digital imaging sensor, intraoral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental digital imaging sensor, intraoral
Hdi2000 by Rayence Co., Ltd. — 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
- Rayence Co., Ltd.
Sources (1)
- FDA UDI c6a1a19a-94e9-4284-9efd-79802b13d1e2 35 fields · synced May 30, 2026