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ChairsideCAD 3.1 Rijeka
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 04260521363039
by exocad GmbH
Identity
- Trade Name
- ChairsideCAD 3.1 Rijeka EUDAMEDChairsideCAD FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- ChairsideCAD EUDAMEDChairsideCAD is a software device intended to support the design of dental restorations such as inlays, onlays, crowns, copings, veneers, bridges, pontics, provisionals, and bite splints via a 3D CAD tool. The design is based on suitable 3D scans of the patient’s dental anatomy produced by a compatible scanner. The software generates geometrical output of the design for manufacturing on compatible CAM systems. ChairsideCAD is intended to be used by trained professionals in dental practices and is not to be used for any purpose other than the design of dental restorations or bite splints, nor is it to be used for designing dental abutments. FDA UDI
- Model / Reference
- 04260521363039 EUDAMED3.1 Rijeka FDA UDI
- Description
- ChairsideCAD is a software device intended to support the design of dental restorations such as inlays, onlays, crowns, copings, veneers, bridges, pontics, provisionals, and bite splints via a 3D CAD tool. The design is based on suitable 3D scans of the patient’s dental anatomy produced by a compatible scanner. The software generates geometrical output of the design for manufacturing on compatible CAM systems. ChairsideCAD is intended to be used by trained professionals in dental practices and is not to be used for any purpose other than the design of dental restorations or bite splints, nor is it to be used for designing dental abutments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260521363039 EUDAMEDFDA UDI
- Basic UDI-DI
- 426052136DENTAL21FF EUDAMED
- Direct Marketing DI
- 04260521363039 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental milling system, CAD/CAM, chairside FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ChairsideCAD 3.1 Rijeka by exocad GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426052136DENTAL21FF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- exocad GmbH
- EUDAMED SRN
- DE-MF-000007341
Sources (2)
- EUDAMED 93d66288-9ab4-460f-ab87-69c3e2fd2e7c 61 fields · synced Jul 22, 2026
- FDA UDI f8fd4836-ad84-4790-9faf-2b85e048fc20 34 fields · synced May 30, 2026