Terms & Conditions

Last updated: September 2026

1. Introduction

These Terms & Conditions ("Terms") govern the relationship between ELVYTA ("ELVYTA", "we", "us" or "our") and any dental professional, clinic, or organisation ("you" or "the Customer") that orders, purchases, or uses our clear orthodontic aligners, retainers, and related design and manufacturing services (together, the "Products and Services"). By placing an order or using our website, you agree to be bound by these Terms.

2. Definitions

"Aligner" means a clear orthodontic appliance manufactured by ELVYTA. "Prescription" means the clinical instructions, scans, and treatment goals you submit. "Setup" means the digital treatment plan we prepare for your approval. "Case" means a complete course of treatment for one patient. "Website" means the ELVYTA website and any related online tools.

3. Who we supply

ELVYTA supplies registered dental professionals only. Our Products and Services are intended to be prescribed, ordered, and supervised by a qualified and appropriately licensed dentist or orthodontist. We do not sell directly to patients or members of the public. By ordering, you confirm that you are a licensed dental professional (or are ordering on behalf of one) and are authorised to prescribe orthodontic treatment in your jurisdiction.

4. Clinical responsibility

You retain full clinical responsibility for the diagnosis, treatment planning, prescription, supervision, and outcome of every case. ELVYTA manufactures appliances to the Prescription and approved Setup you provide; we do not practise dentistry, diagnose patients, or make clinical decisions on your behalf. You are responsible for assessing each patient's suitability for aligner treatment, for obtaining informed consent, and for monitoring treatment progress. Any clinical guidance, default parameters, or suggestions provided by ELVYTA are for reference only and do not replace your professional judgement.

5. Orders, prescriptions and approvals

Each order must include the required scans, records, and Prescription. We will prepare a Setup for your review. No aligners are manufactured until you approve the final Setup in writing (including via our online tools). You are responsible for reviewing each Setup carefully and confirming that it reflects your clinical intent before approval. Once a Setup is approved and manufacturing has begun, changes may not be possible or may incur additional charges.

6. Manufacturing and delivery

We aim to manufacture and dispatch approved cases within the timeframes indicated to you, but any dates provided are estimates and are not guaranteed. Delivery times depend on couriers and other factors outside our control. Risk in the Products passes to you on delivery. We are not liable for delays caused by incomplete records, late approvals, courier issues, customs, or events beyond our reasonable control.

7. Pricing and payment

Prices are as quoted or as set out in your agreed pricing schedule and may be updated from time to time. Unless otherwise agreed in writing, payment terms, applicable taxes, and any shipping charges will be confirmed with your order. We reserve the right to suspend Products and Services where payment is overdue.

8. Remakes, cancellations and returns

Because aligners are manufactured to a specific patient's prescription, they are bespoke medical devices and cannot be resold or returned for general refund. Remakes, refinements, and replacements are handled in accordance with the case terms agreed with you. If you believe a Product is defective or does not conform to the approved Setup, you must notify us promptly so we can investigate.

9. Intellectual property

All intellectual property in our Products, Setups, software, designs, processes, and Website remains the property of ELVYTA or its licensors. You are granted a limited, non-transferable right to use the Setups and Products for the treatment of the specific patient for which they were supplied. You retain ownership of the patient records and scans you provide, and grant us the rights necessary to use them to deliver the Products and Services.

10. Confidentiality and data protection

Each party will keep the other's confidential information secure. Patient data and records are processed only to provide the Products and Services and in accordance with applicable data-protection laws. You are responsible for obtaining any patient consents required for you to share records with us. Further detail is set out in our Privacy Policy.

11. Regulatory and medical device status

ELVYTA aligners are medical devices and must be prescribed and used in accordance with applicable regulations and with our instructions for use. You are responsible for ensuring that your use of the Products complies with the laws and regulatory requirements applicable in your jurisdiction. [Regulatory registrations and conformity details to be confirmed.]

12. Warranties and disclaimers

We warrant that the Products will be manufactured to conform materially to the approved Setup using reasonable skill and care. To the fullest extent permitted by law, all other warranties, whether express or implied, including any implied warranty of fitness for a particular purpose or of a particular clinical result, are excluded. ELVYTA does not warrant any specific treatment outcome, which depends on clinical factors and patient compliance outside our control.

13. Limitation of liability

Nothing in these Terms limits liability that cannot be limited by law. Subject to that, ELVYTA is not liable for any indirect, incidental, or consequential loss, or for loss of profit, goodwill, or clinical outcome, arising from the Products and Services. Our total aggregate liability arising out of or in connection with any case is limited to the amount paid by you for that case.

14. Indemnity

You agree to indemnify ELVYTA against claims, losses, and costs arising from your clinical decisions, your failure to obtain patient consent, your breach of these Terms, or your use of the Products otherwise than in accordance with our instructions and applicable law.

15. Governing law

These Terms, and any dispute arising out of or in connection with them, are governed by the laws of [jurisdiction to be confirmed], and the courts of that jurisdiction have exclusive jurisdiction, unless otherwise required by mandatory law.

16. Changes to these Terms

We may update these Terms from time to time. The version in force is the one published on this page at the time you place an order. We encourage you to review these Terms periodically.

17. Contact

Questions about these Terms can be sent to ceo@elvyta-aligners.com or by telephone on +30 698 036 3099.