Identity
- Trade Name
- NobelClinician® FDA UDI
- Generic Name
- General-purpose dental x-ray system application software FDA UDI
- Device Name
- NobelClinician 3.1 for Windows 64-bit FDA UDI
- Model / Reference
- 3.1 FDA UDI
- Description
- NobelClinician 3.1 for Windows 64-bit FDA UDI
Identifiers
- Catalog Number
- 101560 FDA UDI
- Primary DI / UDI-DI
- 07332747125160 FDA UDI
- 510(k) Number
- K163122 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- General-purpose dental x-ray system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
NobelClinician® by Nobel Biocare AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Nobel Biocare AG
Sources (1)
- FDA UDI 2260e073-6f32-4de5-b2c1-37ff5070c8db 37 fields · synced May 31, 2026