Ceramill Mind DRS 3.1
EUDAMEDFDA UDIClass IIa (EU MDR)
by exocad GmbH
Identity
- Trade Name
- Ceramill Mind DRS 3.1 EUDAMEDCeramill Mind DRS FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- ChairsideCAD EUDAMEDCeramill Mind DRS 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. Ceramill Mind DRS 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
- 04260521363312 EUDAMED3.1 FDA UDI
- Description
- Ceramill Mind DRS 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. Ceramill Mind DRS 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
- 04260521363312 EUDAMEDFDA UDI
- Basic UDI-DI
- 426052136DENTAL21FF EUDAMED
- Direct Marketing DI
- 04260521363312 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental appliance fabrication material, ceramic
Ceramill Mind DRS 3.1 by exocad GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 f2dc95af-a9d5-4795-906e-d4394f9367d5 61 fields · synced Jul 10, 2026
- FDA UDI dd916741-2039-430b-9d4b-6fcfa615e6b7 34 fields · synced May 30, 2026