AbutmentCAD

GUDID 04260521363534

The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

exocad GmbH

Dental milling system, CAD/CAM, chairside

• Primary Device ID: 04260521363534
• NIH Device Record Key: c6e9a5dd-993f-4990-98b7-6e9f53566c7f
• Commercial Distribution Discontinuation: 2024-01-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AbutmentCAD
• Version Model Number: 3.2
• Company DUNS: 341575872
• Company Name: exocad GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	04260521363534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193352

FDA Product Code

• PNP: Dental Abutment Design Software For Dental Laboratory

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-23
• Device Publish Date: 2024-01-10

On-Brand Devices [AbutmentCAD]

• 04260521363510: The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially
• 04260521363527: The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially
• 04260521363534: The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially