Device name: Maestro 3D Dental Studio Expert
Device Version: 7.00.00.30000
Certifications: Class IIa Medical Device; certification according to MDR 2017/745 CE
Rev. 03 del 02/05/2024
Name of manufacturer: AGE Solutions S.r.l.
Registered office: Via Salvo d'Acquisto 38/a, 56025, Pontedera, Pisa, Italy
Operating site: Via Salvo d'Acquisto 38/a, 56025, Pontedera, Pisa, Italy
Contact details:
Phone: +39 0587 213256;
Mail: info@age-solutions.com
Web: www.maestro3d.com
Maestro 3D Dental Studio Expert is a software based on a totally proprietary technology and it represents a complete tool for the realization of orthodontic treatments and for the design of aesthetic and functional dental appliances based on individual dental anatomy of the patients.
The software includes two working areas: Order Management and Dental Studio.
The Order Management is the application for managing the customer database, creating a new work case and opening an existing one. This software application does not have a medical purpose, as defined in MDR Regulation, so it does not fall within the definition of a medical device.
Maestro 3D Dental Studio Expert can import digital 3D files from 3D scans and 2D images (as patients photos), then it analyzes, modifies the input files with the aim to create a set of 3D models needed for orthodontic and restorative treatments. The 3D input files can originate from 3D intraoral or extraoral scanner, in particular structured light or laser scanner.
Maestro 3D Dental Studio Expert is a tool that allows predictable results (through the creation of 3D models), improving communication between the dental technician, doctor and patient. The software is modular and it is composed by two main macro modules: Ortho Studio and Smile Creator.
Maestro 3D Dental Studio Expert is a stand-alone software which is not distributed by a physical support. It is distributed to the customer by sending through email the link to download the information material and the executable file of the software. So, the software does not require any packaging. At the same time, Age Solutions provides a dongle USB as protective hardware for use. This latter is defined as an accessory of a medical device and classified accordingly.
The software Maestro 3D Dental Studio Expert is a medical device intended to be used exclusively by qualified personnel (dental technicians and dentists) to provide information to take decisions for the diagnosis and planning of orthodontic treatments and for the design of aesthetic and functional dental appliances based on individual dental anatomy of the patients.
In particular, Maestro 3D Dental Studio Expert software allows the technician/dentist:
Therefore, the software is intended to guide and assist the user (dental technician/dentist) in planning and design of orthodontic treatments and devices as listed below:
The described device is a stand-alone software intended to be used only by qualified personnel represented by dental technicians (mostly) and dentists. Therefore, it is recommended that the user has the appropriate expertise and training in orthodontic and prosthetic dentistry. Furthermore, it is important that the user is familiar with the use of 3D digital technologies.
The dentist and the dental technician can use the software in the same way and all the functions available for the purposes of the intended use and indications for use.
The software is intended to guide and assist the user (dental technician/dentist) in planning and design of orthodontic treatments and devices as listed below:
The software allows the user to:
The device must be installed and used according to the specific instructions provided by Age Solutions in this manual.
The software is intended to be used in adults subjects (>16years) who need orthodontic or restorative treatments which include:
The device Maestro 3D Dental Studio Expert can import digital 3D files from 3D scans and 2D images (as patients' photos).
Then the software analyzes, modifies the input files with the aim to:
in order to physically realize the piece designed by the software.
Input files can originate from an extraoral scanner (3D scans of dental impressions) or from the 3D intraoral scanner. These can be laser scanners or structured light scanners. Allowed formats for the input data (3D models) are ..STL, .PLY, .OBJ.
2D images must be in .bmp,.jpg, .png, .tga file format.
It is also possible to import .xml files only for 4D motion function, which allows to apply a list of animations to the model of the lower dental arch. It has the only purpose of visualization and it is not possible to perform measurements or analysis on models.
The software Maestro 3D Dental Studio Expert can not import DICOM files nor input images from CT or CBCT.
The software exports digital 3D files (output) in the following formats: .STL, .PLY, .OBJ, .ZIP-STL, .ZIP-PLY, .ZIP-OBJ.
Output files represent the inputs of other software that manipulate these data and then transfer them to machineries such as 3D printers and CNC machines (e.g. thermoforming machines), which physically realize the piece designed by the software.
Technical contraindications:
Medical Contraindications:
Orthodontic treatments including brackets, clear aligners or bite are not indicated in case of severe gum recession, periodontitis, chronic inflammation and, in general, where other dental diseases coexist. A basic dental health is a prerequisite for the applicability of the described treatments. Regarding the Denture Guide application, as it is intended for edentulous patients, no inflammation nor other gum pathological conditions should be present.
The software Maestro 3D Dental Studio Expert does not provide by itself diagnosis or therapies, it is a tool to support dental professionals in performing orthodontic and restorative treatments through acquisition, processing and analysis of 3D images with the aim to create 3D models needed for the treatments.
Medical decisions cannot be based exclusively on data/analysis provided by the software. Diagnostic and therapeutic decisions are under the responsibility of the qualified personnel authorized for use of the software.
Check the hardware compatibility (e.g 3D scanner, PC configuration, etc..) before using Maestro 3D Dental Studio Expert software and verify that input 3D models\images are of adequate quality.
Refer to sections:
Success of 3D model output could be affected by poor quality input 3D models\images or inadequate hardware.
Access to the software is only possible through the hardware key (dongle USB), by which the software is distributed following the purchase of the license. If the USB key is not inserted, the software will send you a message.
The software can work only when the hardware key is connected to the workstation. It is recommended not to leave the workstation unattended with the hardware key connected, in order to avoid unauthorized access to the software.
After 60 minutes of inactivity, the software turns itself off, automatically saving the data.
To set the autosave at the end of each critical step, please follow the instructions given at section Settings (1)
For backup procedure refer to section How can I make a backup of all work cases?
It is highly recommended to activate a protection against malware ( e.g. anti-virus software, use of firewall).
Note: in case of cybersecurity incident, such as a violation of the informatic system by malware or unauthorized access, reading the work data in clear text is not possible without the use of the appropriate hardware key.
Any event, such as malfunction or deterioration in terms of performance of the device, that caused or might have caused or might cause death or serious deterioration of the health of the patient or the user, should be reported to the manufacturer and the competent authority of the Member State in which the user is established.
For contact details for reporting refer to General information.
The expected life of the software can be estimated in 5 years, taking into account the technological advance and the obsolescence of software, which require the release of new versions.
Video Tutorials
Minimum Configuration:
Recommended Configuration:
To install the software, run the installation file with administrator rights. In the various phases of the installation process, it will be possible to choose the destination folder, whether or not to add an icon to our desktop, etc. See the image below which shows an installation step.
This operation takes a few minutes. At the end of the operation, the installation will have created two icons on the desktop
Before starting check:
At the first run the software will show a window like this:
Press Ok to activate the license.
The activation procedure, described above, activates the license on the workstation.
It is necessary to repeat the activation procedure each time the workstation is modified or changed. For this reason, it is recommended to keep the product code.
The maximum number of workstations that can be activated is 5. However, the license cannot work simultaneously in more than one workstation.
The software requires an internet connection.
The Order Management application allows you to manage work cases.
To create a new work case:
To achieve a work case, at least one arch (upper or lower) must be loaded.
By using the cloud integration function (if activated) you can store the encrypted case in a remote repository and share it across registered users. Username and password are necessary to access the cloud.
Pending cases are new work cases to process that have been uploaded to the cloud by a viewer user who is part of the workgroup via the cloud platform.
The viewer user through the cloud platform enters the data of the patient, doctor, clinic and input files and waits for their processing.
To create a new work case starting from a pending case on the cloud, right-click on the selected case, activate the context menu and select the item1;
After the import phase and the download of the input files, the areas relating to the clinic, doctor and patient and the input files of the initial screen will be populated.
To start the new case press the Next button.
To open an existing work case:
The next image shows the preview of the selected case.
All these tools mentioned above are also accessible via the context menu of the work case.
After importing the case from the cloud 1, the case will appear in the local case table.
The image below shows how the software user interface appears.
All input data representing three-dimensional models are considered to be in millimeters (or degrees/radiants for angles).
The maximum approximation error that occurs in all the measurement operations listed above is of the order of 10-7.
The maximum measurement error is in the order of 0.005 mm.
For more details see the list below:
The display and work area is the area of the window where the 3D models are displayed and where editing operations are allowed. In the display area, it is possible to view/create the virtual bases, view the occlusion between the maxilla and the mandible, view the dimensions of the teeth, the length of the arch, and realize and show the virtual setup and all the other phases of the work.
The chamber parameters (position, scaling, rotation) can be set using an instrument called trackball to examine the displayed models. The trackball is a simple tool to use to move and interact with the 3D scene.
The information area located in the lower-left corner of the main screen contains all the main information of the work case. For example, the name of the clinic, the doctor, the patient data, the identification of the work case, and the currently displayed models are shown.
As shown in the figure, press on the menu 1 item:
The software will show a screen like the one shown in the figure below::
The medium must be disposed of according to regulations in force for waste electrical and electronic equipment.
As shown in the figure, activate the menu 1 e and press 2.
The software will show a screen like the one shown in the figure below:
To delete the software license from the workstation, hold down the CANC\DELETE key on the keyboard as shown in the figure below and then press (6 Close the screen) of the previous about screen.
At the next restart, the software will ask you to repeat the activation procedure.
This operation is usually done when new configurations\modules have been added to the license or when we want to change the activation parameters such as email address and\ or name of the station.
The product key is a code consisting of 12 numbers with the following format XXX-XXX-XXX-XXX.
This code was provided to the license holder by e-mail at the time of purchase and/or can be found written on the label of the box containing the USB dongle. See the image below.
This code is necessary to carry out the first activation of the software on a new PC.
We recommend that you keep this code, as it may be necessary to install a new software update or new modules.
A message will show if there are any updates or not.
Input models must be STL\PLY\OBJ files recorded in the correct occlusion;
2D images must be in .BMP, .JPG, .PNG, .TGA file format;
Press 1 and the following window will appear:
Meaning of the symbols used on the product labels:
Design and print your aligners. Thermoforming or direct printing.
Automatically place brackets, choosing from various techniques such as Step, Roth, Wick Alexander, Dwight Damon, MBT, Andrews, and print your personalized guides.
Design and print a wide range of occlusal bite splints, nightguards, occlusal splints, and much more.
Design appliances and customize the framework for output using all types of 3D-driven machines and materials. Bands, supports, expander arms, retainers, and much more.
Design aesthetic mockups and guides for the creation of prostheses for edentulous patients.
Full integration with leading CNC and Laser machine manufacturers for aligner cutting.
Design and automatically create variable-thickness aligners optimized for direct 3D printing.
Expert Mode offers advanced features with access to remote computing servers that leverage parallelism and AI to enhance the user experience. It also ensures continuous updates and direct technical support, delivering state-of-the-art service.
The Web Viewer allows viewing the treatment and is accessible from any device. It provides a link that can be integrated into web pages or shared via email and WhatsApp.