Terms and Conditions of Use (TCU)

Preamble

These general terms of use (the “Terms of Use”) govern access to and use of the Practitioner Area of the eztain.com website. They are entered into between:

• eZtain Lab, a French simplified joint-stock company (SAS) with a share capital of €31,000, whose registered office is at 3 rue Marie Hamm, 67000 Strasbourg, France, registered with the Strasbourg Trade and Companies Register under no. 951 635 143, tel. +33 9 87 39 43 80, email contact@eztain.com (“eZtain”);
• and any professional who opens an account on eztain.com (the “Customer”).

Version of 28 October 2026, applicable from that date. It replaces all previous versions of the Terms of Use.

The Terms of Use govern the account, the use of the Practitioner Area and the data transmitted through it, in particular patient data. The sale of Products is governed by the general terms and conditions of sale (the “Terms of Sale”). For all matters relating to the sale of Products, the Terms of Sale prevail over the Terms of Use in the event of conflict.

Article 1 – Definitions

The terms Practitioner, Reseller, Product, Retainer, Order, Practitioner Area, Order Form and Business Day have the meaning given to them in the Terms of Sale. In the Terms of Use, the following terms also apply:

• Customer: any professional holding an Account, whether a Practitioner or a Reseller, whether or not they have already placed an Order;
• Account: the account opened in the Customer’s name, which gives access to the Practitioner Area;
• User: the Customer and any person the Customer authorises to use its Account;
• Login Details: the email address and password used to access the Account;
• Patient Identifier: the designation chosen by the Practitioner to link a patient’s impression to their prescription;
• Patient Data: the Patient Identifier, the digital impression (intraoral scan) and the prescription transmitted for an Order;
• Transmission Platform: the Digilab platform, which centralises the impressions sent from intraoral scanner software and forwards them to eZtain;
• Practitioner Map: the page of the eztain.com website that presents the Practitioners who have ordered eZtain Products.

Article 2 – Purpose and acceptance

2.1. The Terms of Use set out the conditions for opening and using the Account, the parties’ commitments regarding Patient Data, and the conditions for suspending and closing the Account.

2.2. The Customer accepts the Terms of Use by ticking the box provided for that purpose when registering, then with each Order placed on the eztain.com website. The Customer ensures that the Users it authorises comply with them.

2.3. The applicable version is the one in force on the date the Practitioner Area is used. The Terms of Use may be consulted at any time on eztain.com.

2.4. Opening and using the Account are free of charge. Products are invoiced under the conditions of the Terms of Sale.

Article 3 – Accounts reserved for professionals

3.1. An Account may only be opened by a Practitioner or a Reseller, for the purposes of its professional activity. An individual, in particular a patient, may not open an Account.

3.2. Registration. The Customer completes the registration form with accurate and complete information: identity, name of the practice or company, SIREN number and VAT number (or their foreign equivalents), delivery and billing addresses, email address and WhatsApp number. The Customer informs eZtain without delay of any change, by email to contact@eztain.com.

3.3. Verification. eZtain verifies the Customer’s professional status on the basis of its SIREN number or foreign equivalent, and may request any relevant supporting document. eZtain may refuse to open an Account, in particular where that status is not established.

3.4. Customer’s representations. The Practitioner represents that they are legally authorised to practise in their country and to prescribe the Products. The Reseller represents that it only places Orders on the prescription of a qualified Practitioner (Article 18 of the Terms of Sale).

Article 4 – Account, Login Details and Users

4.1. Account holder. Each Account is personal. It is opened in the name of a single Practitioner, or of a single Reseller.

4.2. Authorised Users. The Customer may allow members of its staff (assistants, secretaries) to use its Account, under its responsibility. The Customer ensures that they comply with the Terms of Use.

4.3. One Account per Practitioner. Each Practitioner, including within the same practice, opens their own Account. The manufacturing documentation for each Product thus identifies the prescribing Practitioner, as required by Annex XIII of Regulation (EU) 2017/745.

4.4. Confidentiality of Login Details. Login Details are confidential. The Customer does not disclose them to anyone outside its practice or company and chooses a strong password. The Customer informs eZtain without delay, by email to contact@eztain.com, of any loss of Login Details or any unauthorised use of the Account. eZtain may then block access and reset the password.

4.5. Actions taken from the Account. Any Order and any action taken from the Account are deemed to have been taken by the Customer, who bears the consequences. This rule does not apply to actions taken after the notification provided for in Article 4.4.

Article 5 – Practitioner Area services

5.1. Features. The Practitioner Area allows the Customer, in particular:

• to fill in the prescription and place an Order on the Order Form;
• to attach digital impressions to its Order;
• to track its Orders and their delivery;
• to consult the traceability records of its Products;
• to consult the instructions for use and the bonding protocol (FAQ section);
• to consult the balance of its prepaid pack (Article 8 of the Terms of Sale);
• to save its addresses and preferences, in particular the procedure to follow in the event of a deep bite.

eZtain may change these features, in particular to improve them or to bring them into line with regulations.

5.2. Transmission of impressions. The Customer transmits its impressions by attaching them to the Order Form, or by sending them from its intraoral scanner software to eZtain Lab. In the latter case, the impressions reach eZtain via the Transmission Platform. The use of the scanner software and of its publisher’s platform is governed by the terms agreed between the Customer and that publisher.

5.3. Matching the impression and the prescription. The Customer enters the same Patient Identifier in its scanner software and on the Order Form, so that eZtain can link the impression to the prescription without ambiguity. Failing that, eZtain contacts the Customer and lead times do not run (Articles 5.4 and 11.4 of the Terms of Sale).

5.4. Clinical assessment. By validating their prescription, the Practitioner confirms that they have carried out the clinical assessment of their patient and considered that the prescribed Product is suitable for them.

5.5. Sale. The formation of the sale, prices, payment, manufacturing, delivery, claims and warranties are governed by the Terms of Sale.

Article 6 – Patient data

6.1. Respective roles. Patient Data are health data within the meaning of Article 9 of Regulation (EU) 2016/679 (GDPR). The Practitioner is responsible for the processing carried out in their practice, in particular the collection of their patient’s data and its transmission to eZtain. For the design, manufacture, inspection and documentation of the Products, eZtain acts as controller, by virtue of its obligations as a manufacturer of custom-made medical devices (Regulation (EU) 2017/745). This processing is described in eZtain’s privacy policy, available on eztain.com.

6.2. Informing the patient. Before transmitting an Order, the Practitioner informs their patient:

• that the impression of their teeth, their prescription and the Patient Identifier are transmitted to eZtain, the manufacturing laboratory, for the manufacture of their device;
• that impressions, with any name and Patient Identifier removed, may be used to improve eZtain’s design tools (Article 6.7);
• that they can consult eZtain’s privacy policy on eztain.com.

The Practitioner remains solely responsible for the prescription and the clinical assessment (Article 15 of the Terms of Sale). The Reseller ensures that the prescribing Practitioner complies with this Article.

6.3. Patient Identifier. The Practitioner freely chooses the Patient Identifier: file number, surname and first name, or abbreviated surname and first name. eZtain recommends a non-nominative identifier, such as a file number. The Patient Identifier must be identical in the Order and in the scanner software (Article 5.3).

6.4. Strictly necessary data. The Customer only transmits the data necessary for manufacturing: the Patient Identifier, the impression and the prescription. The Customer transmits no other data about the patient, in particular their date of birth, address, social security number, photograph or medical history, whether in the fields of the Order Form, in the files or in the file names.

6.5. Exchanges outside the Practitioner Area. Exchanges about an Order by email, WhatsApp or telephone use the Order number. The Patient Identifier is only mentioned where necessary, for example to link an impression to an Order. No other patient data is exchanged through these channels. The design images sent for approval (Article 5.5 of the Terms of Sale) only show the digital model and the design.

6.6. eZtain’s commitments. eZtain processes Patient Data confidentially. Its staff are bound by confidentiality. It implements security measures suited to health data and works internally with the Order number. It keeps Patient Data for the period stated in its privacy policy, namely 10 years after manufacture for the documentation required of a manufacturer of custom-made devices, and then deletes them.

6.7. Improvement of design tools. eZtain may use impressions and designs, after removing any name and any Patient Identifier, to improve its design tools, including artificial intelligence tools running on its own servers. Such data are not disclosed to third parties and are kept under the same conditions as the manufacturing documentation (Article 6.6).

6.8. Patients’ rights. Where a patient exercises with the Practitioner a right concerning data transmitted to eZtain, the Practitioner forwards the request to contact@eztain.com, stating the Order number. The parties cooperate to respond within the legal time limits. eZtain may keep the data it is required by law to keep, in particular under its obligations as a manufacturer.

6.9. Security incident. Each party informs the other without delay of any personal data breach of which it becomes aware and which concerns Patient Data transmitted by the Customer. Each party fulfils its own obligations to notify the supervisory authority and the data subjects.

Article 7 – Customer data and Practitioner Map

7.1. eZtain processes the personal data of the Customer and of Users (identity, contact details, Account data, Orders, invoices, exchanges) in accordance with its privacy policy. The policy sets out the purposes, legal bases, retention periods, recipients and the rights of data subjects.

7.2. Practitioner Map. From their first Order, the Practitioner appears on the Practitioner Map, with their title, first name, surname and practice address. This processing is based on the legitimate interest of eZtain and its Practitioner customers in making known the practices that offer its Products (Article 6(1)(f) GDPR).

7.3. The Practitioner may ask at any time to be removed from the Practitioner Map, by simple email to contact@eztain.com, without having to give reasons. Removal has no effect on their Orders.

Article 8 – Communications

8.1. Order-related exchanges. eZtain contacts the Customer by email, WhatsApp or telephone for the performance of its Orders: requests for additional information, design approval, follow-up. The WhatsApp number is requested at registration for this reason. These exchanges comply with Article 6.5.

8.2. Notifications and marketing communications. When registering, the Customer chooses whether or not to receive order tracking notifications and eZtain’s communications about its products and services. The Customer may object at any time to marketing communications, free of charge, via the link in each email or by writing to contact@eztain.com.

8.3. Notices under the Terms of Use and the Terms of Sale. Notices provided for in the Terms of Use and the Terms of Sale are validly given by email: to the Account email address for the Customer, and to contact@eztain.com for eZtain.

Article 9 – Customer obligations and prohibited uses

9.1. The Customer uses the Practitioner Area for the purposes of its professional activity, in good faith and in compliance with the law and the rules of its profession.

9.2. The Customer and Users are prohibited from:

• opening an Account on behalf of a person who is not a professional, or using false information;
• giving access to the Account to persons outside the Customer’s practice or company;
• undermining the security or operation of the website, in particular by attempted intrusion, sending malicious files or automated data extraction;
• transmitting files unrelated to an Order;
• transmitting Patient Data in breach of Article 6;
• using the Practitioner Area or its content to copy eZtain’s Products or designs, or to compete with eZtain (Article 17 of the Terms of Sale).

Article 10 – Availability and security

10.1. eZtain endeavours to keep the Practitioner Area accessible at all times, without being able to guarantee it. Access may be interrupted for maintenance, an update, a technical incident or an event of force majeure. eZtain gives notice of scheduled maintenance where it can. During an interruption, the Customer may transmit its impressions via the Transmission Platform and contact eZtain at contact@eztain.com.

10.2. The eztain.com website and the impressions uploaded to it are hosted by OVH, a host certified for health data (HDS). eZtain implements technical and organisational measures to protect the Account and the data. The Customer, for its part, secures its equipment, its connection and its Login Details.

10.3. eZtain keeps the manufacturing documentation for the period provided for in Article 6.6. The Customer may obtain a copy on request, in particular the traceability records of a Product. This retention by eZtain does not release the Practitioner from keeping in their patients’ records the documents required by the rules that apply to them.

Article 11 – Intellectual property

11.1. The eztain.com website, the Practitioner Area and their content (texts, instructions for use, videos, illustrations, software, databases, trademarks and logos) are protected by intellectual property law. They belong to eZtain or its partners. eZtain’s rights in its Products, patents, trademark and designs are described in Article 17 of the Terms of Sale.

11.2. eZtain grants the Customer a personal, non-exclusive and non-transferable right to use the Practitioner Area and its content for the purposes of its activity, for the duration of its Account. The Customer may download and print the instructions for use and the traceability records for its professional use and to inform its patients. Any other reproduction or distribution requires eZtain’s written consent.

11.3. The Customer warrants that it has the right to transmit the files it uploads. It authorises eZtain to use them to perform its Orders, to keep the manufacturing documentation and, with any name and Patient Identifier removed, to improve its design tools (Article 6.7).

Article 12 – Suspension and closure of the Account

12.1. Term. The Account is opened for an indefinite period. eZtain does not close it solely because it is inactive, so that the Customer keeps access to the traceability records of its Products. An Account with no Order for 10 years may be closed, after the Customer has been informed by email.

12.2. Closure by the Customer. The Customer may close its Account at any time, by email to contact@eztain.com. Orders in progress are performed and invoiced under the Terms of Sale, and amounts due remain payable. The remaining credit of a prepaid pack is not refunded; before closure, the Customer may request its transfer to another eZtain account (Article 8.5 of the Terms of Sale).

12.3. Suspension by eZtain. eZtain may suspend all or part of the access to the Account in the event of a breach of the Terms of Use, suspected fraudulent use or a security threat, or while the Customer’s professional status is being verified. The suspension of Orders in the event of non-payment is governed by Article 10.3 of the Terms of Sale.

12.4. Closure by eZtain for a reason attributable to the Customer. eZtain may close the Account in particular where:

• the Customer’s professional status is not established or has ceased;
• the Customer has provided false information;
• the Account is used fraudulently or threatens the security of the website;
• the Customer infringes eZtain’s rights (Article 17 of the Terms of Sale);
• the Customer commits a serious or repeated breach of the Terms of Use or the Terms of Sale.

In the event of fraud or urgency, closure is immediate, without notice. In other cases, eZtain first gives the Customer formal notice, by email, to remedy the breach within 15 days. The remaining credit of a prepaid pack is then not refunded.

12.5. Closure by eZtain through no fault of the Customer. eZtain may close an Account through no fault of the Customer, in particular if it ceases its business, with 30 days’ notice given by email. The remaining credit of a prepaid pack is then refunded (Article 8.4 of the Terms of Sale).

12.6. Effects of closure. Access to the Account ends and the Practitioner is removed from the Practitioner Map. eZtain keeps the data it is required by law to keep, in particular the manufacturing documentation and accounting records, for the periods set out in its privacy policy. The Customer may still obtain a copy on request (Article 10.3).

Article 13 – Liability

13.1. For the Practitioner Area, eZtain has an obligation of means (best efforts). It is not liable for:

• a temporary interruption of access under the conditions of Article 10.1;
• the operation of scanner software, the Transmission Platform, communication networks or the Customer’s equipment;
• the use of the Account by a third party before the notification provided for in Article 4.4;
• the consequences of inaccurate or incomplete information transmitted by the Customer, in particular an incorrect prescription or a Patient Identifier that does not allow the impression to be linked to the Order.

13.2. eZtain is not liable for indirect damage, such as loss of revenue, loss of patients or reputational damage.

13.3. The Customer is responsible for the accuracy and lawfulness of the data it transmits, for informing its patients (Article 6.2) and for the use of the Account by its Users.

13.4. eZtain’s liability relating to the Products is governed exclusively by Articles 14 to 16 of the Terms of Sale.

13.5. The limitations in this Article do not apply in the cases provided for in Article 16.5 of the Terms of Sale, in particular in the event of gross negligence or wilful misconduct and to personal injury.

Article 14 – Amendments to the Terms of Use

14.1. eZtain may amend the Terms of Use. The new version is published on eztain.com with its effective date, and the Customer is informed by email before that date. The Customer accepts it by ticking the box provided when placing its next Order.

14.2. A Customer who refuses the new version may close its Account under the conditions of Article 12.2.

14.3. An amendment required by law or necessary for the security of the website may apply as soon as it is published.

Article 15 – Language and severability

15.1. The Terms of Use are drawn up in French and translated into English. In the event of any discrepancy, the French version prevails.

15.2. If a clause of the Terms of Use is held to be void or unenforceable, the other clauses remain in force.

Article 16 – Governing law and disputes

16.1. Governing law. The Terms of Use are governed by French law.

16.2. Amicable settlement. In the event of a dispute, the first party to act notifies the other in writing. The parties have 30 days to seek an amicable solution before bringing any legal action. This step does not apply to urgent measures.

16.3. Competent court. Where the Customer is a trader (commerçant) or is established outside France, any dispute relating to the Terms of Use or to the use of the Practitioner Area falls within the exclusive jurisdiction of the courts of Strasbourg (France), including in summary proceedings, third-party claims or where there are several defendants.

16.4. In all other cases, in particular for a Practitioner practising as a self-employed professional in France, the competent court is determined in accordance with the ordinary rules of jurisdiction.

16.5. Disputes relating to sales are governed by Articles 23 and 24 of the Terms of Sale.