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IPS CaseDesigner 2.5 for Windows 64-bit
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 300011_V2.5_WIN64
Identity
- Trade Name
- IPS CaseDesigner 2.5 for Windows 64-bit EUDAMEDIPS CaseDesigner® FDA UDI
- Generic Name
- Dental treatment application software FDA UDI
- Device Name
- Diagnostic and treatment software EUDAMEDIPS CaseDesigner 2.5 for Windows 64-bit FDA UDI
- Model / Reference
- 300011_V2.5_WIN64 EUDAMED2.5 FDA UDI
- Description
- IPS CaseDesigner 2.5 for Windows 64-bit FDA UDI
Identifiers
- Catalog Number
- 300011 FDA UDI
- Primary DI / UDI-DI
- 07332747199062 EUDAMEDFDA UDI
- Basic UDI-DI
- 733274700000016275 EUDAMED
- 510(k) Number
- K200810 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11069082 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Dental treatment application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
IPS CaseDesigner 2.5 for Windows 64-bit by Nobel Biocare AB — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200810 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K161634 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 733274700000016275 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (3)
- EUDAMED f58c3b67-670a-41f5-9f81-e034117fe739 61 fields · synced Jul 26, 2026
- FDA UDI 98acdf0f-11de-44ef-9e0a-e510c065f472 36 fields · synced May 30, 2026
- FDA 510(k) K200810 1 fields · synced May 18, 2026