LEGAL NOTICE AND GENERAL TERMS AND CONDITIONS (B2B)

1. Identifying Data and Purpose In compliance with the Spanish Law 34/2002 (LSSI-CE) and Regulation (EU) 2017/745 on medical devices (MDR), the owner of the website www.xortho.es is:

Company Name: Orthonet Technologies S.L. ("xortho"). Tax ID: B88188859. Address: Paseo de la Habana No. 72, 1, 1ºA, 28036 Madrid. Activity: Wholesale distribution of medical devices (NACE 4646). Health License: 8794-PS. EUDAMED Registry (Actor ID): ES-IM-000035623

Professional Sales Notice: Access and purchases on this website are strictly restricted to dental professionals (dental clinics, registered orthodontists, laboratories and authorised distributors). In compliance with Royal Decree 1591/2009 and the MDR, xortho does not sell to the general public. We reserve the right to request supporting documentation (Professional Registration Number, Health Centre Licence or Form 036) before validating any order.

2. Privacy Policy and Data Protection (GDPR + LOPDGDD) Data Controller: Orthonet Technologies S.L. Purposes and Lawful Basis: - Contractual Management (Art. 6.1.b GDPR): To process your orders, billing and shipments. - Legal Compliance (Art. 6.1.c GDPR): Retention of medical device traceability data (Batches/UDI) for a minimum of 10 years as required by the MDR for post-market surveillance. This obligation prevails over user deletion requests. - Customised Commercial Communications (Legitimate Interest - Art. 6.1.f GDPR): Customers: If you have made purchases, we will process your contact details and order history to send you personalised offers for similar products. We carry out basic (non-automated) commercial profiling to ensure advertising is relevant to your clinical practice. You may object to this processing at any time. New prospects: If you are not yet a customer, we will request your express consent (checkbox) for sending news. Recipients: Tax Authority (for Veri*Factu compliance), AEMPS and Health Authorities (in case of surveillance alerts or recalls), Manufacturers (pseudonymised data only for warranty or custom product management). Rights: You may exercise your rights of Access, Rectification, Erasure (except mandatory traceability data), Restriction, Portability and Objection by writing to calidad@xortho.es.

3. Terms of Sale and Distributor Obligations (MDR) xortho acts as Distributor in accordance with Article 14 of Regulation (EU) 2017/745 (MDR).

3.1. Conformity Guarantee and Traceability: All our products bear the CE Marking and, where applicable, the Unique Device Identification (UDI). The Customer (Clinic/Professional) is obliged to maintain downward traceability (recording which batch was used for which patient) to facilitate possible market withdrawals.

3.2. Returns for Defect or Incident (Vigilance): If you detect a quality defect or an incident that could affect patient safety: You must notify calidad@xortho.es immediately stating the Batch and description of the failure. Do not dispose of the product. xortho will organise collection for analysis by the Manufacturer. xortho will notify the incident to AEMPS and the Manufacturer according to MDR legal deadlines. In these cases, xortho will assume all collection and replacement costs.

3.3. Commercial Returns (B2B Withdrawal): For returns due to customer order error or change of mind (material in perfect condition): Period: 14 calendar days. Material must be sealed, with UDI labelling intact and without annotations. Shipping costs borne by the Customer.

4. Electronic Invoicing and Taxation In accordance with the Invoicing Regulation and Veri*Factu legislation (phased implementation from 2026), invoices issued by xortho are unalterable and are recorded in our system ensuring their integrity. Your billing data may be automatically communicated to the Tax Administration.

5. Intellectual Property All photographs, images, designs and visual content on this website are the exclusive property of ORTHONET TECHNOLOGIES SL ESB88188859 and are protected by Royal Legislative Decree 1/1996, of 12 April, approving the revised text of the Intellectual Property Law, as well as applicable international treaties. Downloading, copying, reproduction, distribution, public communication, transformation or exploitation, in whole or in part, of any images on this website in any format or medium, whether for commercial or personal purposes, is strictly prohibited. No licence or implicit permission is granted. Any unauthorised, fraudulent or stolen use of visual content will be traced and will result in the immediate filing of the corresponding civil and/or criminal legal actions.

6. Applicable Law and Jurisdiction For any dispute arising from the sale of medical devices, the parties submit to the Courts and Tribunals of Madrid, waiving any other jurisdiction, given the commercial (B2B) nature of the relationship.