DentoTrack is the first traceability software for custom-made medical devices in dentistry. It secures your practice by ensuring compliance with the European MDR 2017/745 regulation. With its optional integrated scheduling, it organizes your in-house lab and centralizes traceability into a single, simple, and connected tool.
https://www.youtube.com/watch?v=6oTurM7gESE
DentoTrack presentation video
Duration: 1 min 22 sec
Software for certification of your CMDs and traceability of your products
Optimize the management of your custom-made medical devices (CMDs) with our dental-specific software. It allows you to certify your CMDs in compliance with regulations (MDR 2017/745) and ensure full traceability of products, materials, and batches. Simple, secure, and compliant, it centralizes all essential data for rigorous monitoring and peace of mind in your practice.
Option
Planning interne du laboratoire
No more wasted time juggling between post-it notes, notebooks, or scattered Excel files. As an option with OrthoTrack, all production steps are centralized in a single clear and efficient tool. This allows you to confidently delegate traceability management to your assistants, while maintaining full control and security over your organization.
Custom-made medical devices 3D printed
What is it in theory?
Definition of Custom-Made Medical Device (CMD)
According to EU Regulation 2017/745, applicable since May 26, 2021, a custom-made device is defined as a device specifically manufactured based on a written prescription from a person authorized under national law by virtue of their professional qualifications. This prescription specifies the design characteristics under the responsibility of the prescriber, and the device is intended for a specific patient, in response to their needs and medical condition (Public Health Code, Article R5211-6). Manufacturers of custom-made medical devices must follow the procedure described in Annex XIII of Regulation 2017/745.
Requirements for 3D-printed CMDs
3D-printed CMDs must meet several requirements:
- Safety and compliance: Devices must be safe and meet regulatory expectations.
- Qualified procedure: This includes risk analysis and verification of the biocompatibility of the materials used.
- Documentation: Manufacturers must provide documentation demonstrating that these requirements have been met.
Compliance and Declaration
If the CMD meets the definition set out in Article R5211-6 of the Public Health Code, the manufacturer is not required to assign a medical device class. However, the manufacturer must provide a CE declaration of conformity for each device produced, ensuring that all relevant standards and regulations have been met.
YES in your dental practice
TMJ splint
Teeth whitening tray
Surgical guides
Temporary or permanent 3D-printed crowns and bridges
Temporary removable appliance 3D-printed
Protect your dental practice!
By manufacturing your own custom-made medical devices (aligners, retainers, wires, surgical guides, etc.), you are legally considered a manufacturer. As such, traceability is mandatory under European Regulation 2017/745. Without proper traceability, your practice is exposed to various risks.
50
%
Reduction in the average certification time of dental practice devices
99
%
Regulatory compliance rate achieved through the use of DentoTrack
80
%
Increase in the practice’s operational efficiency
Tests and analyses conducted with DentoTrack users
Compatible with all machines
Integrations with your practice software
DentoTrack integrates seamlessly into your daily workflow thanks to its connections with your practice software.
👉 Result: a smooth workflow with no duplicate data entry.
1 single subscription
that protects your entire practice
- Unlimited practitioners
- Unlimited patients
- Unlimited workstations
No hidden fees, no usage limits
Configurable, customizable, and adaptable to all types of dental practice
The DentoTrack Store
29,90€ / month
- Certification of your custom-made medical devices
- Traceability of products used for CMDs
- Certificate history
- Updates included
1 month free
328,90€ / year
- Certification of your custom-made medical devices
- Traceability of products used for CMDs
- Certificate history
- Updates included
Instant activation
7-day trial period
Secure payment with encryption
Easy cancellation (no commitment)
Technical and commercial support
Unlimited updates included
