Identity
- Trade Name
- OnyxCeph³ FDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Model / Reference
- 3.2 FDA UDI
Identifiers
- Catalog Number
- ONYXCEPH32 FDA UDI
- Primary DI / UDI-DI
- D981ONYXCEPH320 FDA UDI
- 510(k) Number
- K213263 FDA UDI
- FDA Product Code
- PNN FDA UDILLZ FDA UDI
- GMDN Term
- CAD/CAM software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI892.2050 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CAD/CAM software
OnyxCeph³ by Image Instruments GmbH — 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
- Image Instruments GmbH
Sources (1)
- FDA UDI 7d4782da-4dff-4eae-a71a-4fc9cab70f7a 34 fields · synced May 30, 2026