Terms and Conditions of Use (TCU)

1. Preamble

These Terms and Conditions of Use (“TCU”) govern the relationship between the eZtain Lab Laboratory (“we”, “our”) and the prescribing healthcare professional (“you”, “your”) who uses our web interface to order custom orthodontic retainers. By using our interface, you agree to be bound by these TCU.

2. Description of Services

eZtain Lab, a simplified joint-stock company (SAS), is a dental prosthetics laboratory specialized in providing custom orthodontic retainers, referred to as eZtain. We primarily serve orthodontists and dentists practicing orthodontics.

3. Registration and User Account

Professional users, including orthodontists and dentists, are required to create an account on our platform to place orders. Registration requires prior validation from us to ensure professionalism and the integrity of our platform. Users must provide accurate and complete information during registration, including name, office address, phone number, and email address. Each user is responsible for maintaining the confidentiality of their account and password.

4. User Responsibility

As a user, you agree to maintain the security of your account and password and to notify us immediately of any suspicious or unauthorized activity. You are also responsible for updating your registration information to keep it accurate. By using our services, you agree to comply with all applicable laws and regulations.

5. Orders

Orders are placed through our online platform, which serves as a medical prescription system. Required order details include patient identification, digital dental impressions, and prescription specifics. Once an order is placed, it is final and cannot be canceled or modified due to the customized nature of our products.

6. Pricing and Payment

We offer competitive pricing for our retainers, with specific rates for clients in France, the European Union, Switzerland, and the United Kingdom. Payment can be made via bank transfer within 30 days, monthly SEPA direct debit, or credit card. Our prices are subject to change.

7. Delivery

Our retainers are shipped via tracked mail and securely packaged to maintain integrity during transport. We offer free delivery throughout Europe. Delivery usually takes 7 days after receipt of the prescription.

8. Returns and Refunds

Due to the custom-made nature of our medical devices, returns and refunds are not accepted.

9. Warranty and Limitation of Liability

We do not offer a standard warranty due to the personalized nature of our products. However, we commit to working with practitioners to resolve any issues and find mutually acceptable solutions. Our liability is limited to the value of the provided device, and we are not responsible for indirect or consequential damages.

10. Data Protection and Use

At eZtain Lab, data privacy is a core priority. We collect only the data necessary to perform our services and commit never to sell or transmit medical data to third parties. For research and development purposes, we may use dental scans and retainer designs in anonymized form.

In accordance with our Privacy Policy, all collected data—whether personal or prescription-related—are handled in strict compliance with applicable data protection laws.

We strictly adhere to the General Data Protection Regulation (GDPR) when processing personal data. You have the right to access your data, request correction of inaccurate data, or request data deletion. However, some rights may be restricted by legal or regulatory obligations, particularly under Regulation (EU) 2017/745 on medical devices (MDR), which requires us to retain certain data to ensure traceability of our custom devices.

11. Responsibilities and Obligations

In accordance with Regulation (EU) 2017/745 on medical devices (MDR), eZtain Lab’s responsibility is limited to the manufacturing of custom orthodontic retainers (eZtain) based on the detailed prescription provided by the prescribing practitioner. As a manufacturer of custom medical devices, we ensure compliance with the general safety and performance requirements stated in Annex I of the MDR.

The prescribing practitioner is responsible for providing a complete and accurate prescription. It is the practitioner’s responsibility to determine the appropriateness of the orthodontic retainer for the patient. By validating the prescription, the practitioner certifies that a clinical evaluation has been conducted, the benefit-risk ratio has been assessed, and the specified device meets safety and performance requirements.

eZtain Lab disclaims any responsibility for errors or omissions in the provided prescription. If a defect or insufficient performance arises due to an incorrect or incomplete prescription, full responsibility lies with the practitioner.

While eZtain Lab ensures the quality and performance of its custom orthodontic retainers, we are not liable for any direct or indirect consequences of device use, including but not limited to injury or damage resulting from use or misuse.

All our eZtain products are manufactured in compliance with the highest quality and safety standards. eZtain Lab operates a quality management system, maintains detailed technical documentation for each device, and ensures traceability in accordance with the MDR.

12. Intellectual Property

Our eZtain orthodontic retainers are protected under patent number FR3070256A1, and the name eZtain is a registered trademark. All content on our website—including but not limited to text, images, graphics, logos, and icons—is the exclusive property of eZtain Lab, except where third-party trademarks, logos, or content are referenced.

Any reproduction, distribution, modification, adaptation, retransmission, or publication of any of these elements, even in part, is strictly prohibited without the explicit written consent of eZtain Lab. Unauthorized use constitutes an infringement of intellectual property rights, punishable under Articles L.335-2 and following of the French Intellectual Property Code.

13. Changes to the TCU

We reserve the right to modify these TCU at any time. Changes take effect upon publication on our website. Continued use of our interface after any modification constitutes acceptance of the updated TCU. It is your responsibility to regularly review the TCU for updates.

14. Governing Law and Jurisdiction

These TCU are governed by and interpreted under French law. Any disputes concerning their interpretation and/or execution fall under the jurisdiction of French courts.