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ChairsideCAD

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 4260521363022Model 3.0Ref 4260521363022

by exocad GmbH

Identity

Trade Name
ChairsideCAD EUDAMEDFDA UDI
ChairsideCAD 3.0 Galway EUDAMED
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
3.0 EUDAMED
4260521363022 EUDAMED
3.0 Galway 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
04260521363022 EUDAMEDFDA UDI
Basic UDI-DI
B-04260521363022 EUDAMED
426052136DENTAL21FF EUDAMED
Direct Marketing DI
04260521363022 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 IIa EUDAMED
Class 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

Category: Dental appliance fabrication material, ceramic

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

Similar devices

Also classified as Dental appliance fabrication material, ceramic.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
exocad GmbH
EUDAMED SRN
DE-MF-000007341

Sources (3)

  • EUDAMED ce73ef05-0133-4eef-979d-5ee948e1bfc1 61 fields · synced Jul 16, 2026
  • EUDAMED 5fb9c180-c857-4dd2-a93d-d21593b21550 61 fields · synced May 19, 2026
  • FDA UDI a1ba16b2-a215-4415-b10a-2d5d4a96714e 34 fields · synced May 30, 2026