Identity
- Trade Name
- DTX Studio™ Clinic FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- DTX Studio Clinic 1.9 for Win 64-bit FDA UDI
- Model / Reference
- 1.9 FDA UDI
- Description
- DTX Studio Clinic 1.9 for Win 64-bit FDA UDI
Identifiers
- Catalog Number
- 300851 FDA UDI
- Primary DI / UDI-DI
- 07332747185768 FDA UDI
- 510(k) Number
- K172224 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiology DICOM image processing application software
DTX Studio™ Clinic by Nobel Biocare AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 16b2b2c1-b2df-4470-b0a3-a4cab46d5353 36 fields · synced May 30, 2026