AbutmentCAD

Basic Information

• Brand Name: AbutmentCAD
• Primary DI: 04260521363510
• Version / Model: 3.0
• Company Name: exocad GmbH
• Labeler DUNS: 341575872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-26
• Public Version: 3
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 3a35a686-466f-4831-a18f-92d35264d45d
• Distribution End Date: 2026-10-26

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	872.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50484	CAD/CAM software	A software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.	No	Active
38597	Dental milling system, CAD/CAM, chairside	An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for the production of the actual devices to be fitted to the patient.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260521363510	GS1

Premarket Submissions

Submission Number	Supplement Number
K193352	000