ChairsideCAD

GUDID 04260521363022

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.

exocad GmbH

Dental CAD/CAM system, chairside

• Primary Device ID: 04260521363022
• NIH Device Record Key: a1ba16b2-a215-4415-b10a-2d5d4a96714e
• Commercial Distribution Discontinuation: 2026-10-26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ChairsideCAD
• Version Model Number: 3.0 Galway
• Company DUNS: 341575872
• Company Name: exocad GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260521363022 [Primary]

FDA Product Code

• NOF: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-03
• Device Publish Date: 2021-10-26

On-Brand Devices [ChairsideCAD]

• 04260521363008: ChairsideCAD is a software device intended to support the design of dental restorations such as
• 04260521363015: ChairsideCAD is a software device intended to support the design of dental restorations such as
• 04260521363022: ChairsideCAD is a software device intended to support the design of dental restorations such as
• 04260521363039: ChairsideCAD is a software device intended to support the design of dental restorations such as