Device Dossier
Dental treatment application software
Device Dossier for Dental treatment application software (Dental treatment application software, Class IIa, sponsor Dental Axess). ARTG record, intended…
- GMDN category: Dental treatment application software
Intended purpose
This is a medical /dental computer programme that is intended to be used to support pre-operative planning for dental device placement using the visualization of the device placement within the images of the patients anatomy. The process is based on a data set from a scanning device and one that supports optical scans of a patients anatomy as well as a virtual prosthetic proposal. The programme allows for the design of a surgical guide to support the placement of endosseous dental devices in guided surgery. The design of the surgical guide is based on a 3D surface data representing the preoperative device positions. The programme exports the planning and design results as a geometrical data and digital 3D model of the surgical guide to support the manufacturer of a separate physical product.