ChairsideCAD

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 4260521363008Model 2.1

by exocad GmbH

Identity

Trade Name: ChairsideCAD EUDAMEDFDA UDI
Generic Name: Dental milling system, CAD/CAM, chairside FDA UDI
Device Name: ChairsideCAD EUDAMED
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
Model / Reference: 2.1 EUDAMEDFDA UDI
4260521363008 EUDAMED
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: 04260521363008 EUDAMEDFDA UDI
Basic UDI-DI: B-04260521363008 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 I EUDAMED
Class II FDA UDI
Regulation Number: 872.3661 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental appliance fabrication material, ceramic

ChairsideCAD by exocad GmbH — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-04260521363008	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: exocad GmbH
EUDAMED SRN: DE-MF-000007341

Sources (2)

EUDAMED 3aff9550-c63c-4858-bb61-9c13819a4b72 61 fields · synced Jul 30, 2026
FDA UDI f646607e-8412-4daa-8f44-cea40ec35c42 34 fields · synced May 30, 2026