Terms of Sale

1. Purpose and scope

These terms of sale govern the relationship between OPAL DENTAL LAB, SAS with a capital of €100, SIREN 107 246 142 (RNE), Route de Lignières, 36130 Déols, France (“the Lab”), and any dentist or dental practice holding a client account (“the Practice”), for the design, manufacture and supply of custom-made medical devices within the meaning of Regulation (EU) 2017/745, and related services (repairs, accessories). They are accepted when the account is created (time-stamped acceptance) and prevail over any other document, unless otherwise agreed in writing.

2. Orders and prescription

Each order placed through the app or the client portal constitutes the practitioner's written prescription within the meaning of Annex XIII of Regulation (EU) 2017/745. The practitioner is solely responsible for the clinical indications, the impressions and scans provided, the prescribed shades and the accuracy of the prescription. The Lab may put an order on hold when the submitted elements are unusable (defective impression, missing information) — the case thread constitutes the record of these exchanges.

3. Prices

Applicable prices are those of the Practice's price list, available at any time in the client portal (“Pricing & lead times”), in euros. Negotiated prices specific to the Practice prevail over the public list. The price and estimated delivery date are displayed before each order is sent; sending the order constitutes acceptance of the displayed price. The Lab may revise its price list with 30 days' notice; orders already placed keep their accepted price.

4. Lead times and delivery

Displayed lead times (French workshop or international route, urgent option) are best-effort commitments computed from receipt of usable elements. Parts travel at the Lab's risk until handed over to the Practice. The Practice checks the parcel on receipt and reports any damage within 48 hours through the app.

5. Payment

Unless otherwise agreed, invoices are issued monthly and payable within 30 days of issue, by bank transfer. Late payment automatically entails: late-payment interest at the ECB rate plus 10 points, a fixed recovery indemnity of €40 per invoice (French Commercial Code, art. L.441-10 and D.441-5), and the Lab's right to suspend pending orders after a formal notice has remained without effect for 8 days.

6. Retention of title

Delivered devices remain the property of the Lab until full payment. Risk transfers upon delivery.

7. Warranty and remakes

The Lab warrants that devices conform to the prescription and are free from manufacturing defects: fixed restorations for 24 months, removable dentures for 12 months from delivery. In case of proven non-conformity, the Lab remakes or adjusts the piece free of charge, upon its return.

• Excluded: defects attributable to the impression, scan or prescription; changes requested after approval of the 3D design or shade; adjustments or repairs carried out by a third party; undisclosed bruxism, drops, poor hygiene or maintenance.
• The practitioner's approval of the 3D design and, where applicable, of the finished-work photos through the app constitutes approval for manufacturing/shipping and is binding.

8. Liability

The Lab's liability is limited to direct and foreseeable damage and capped, for all causes relating to an order, at the price of that order — excluding personal injury and gross or wilful misconduct, which cannot be capped. The practitioner remains solely responsible for the fitting procedure and clinical follow-up.

9. Traceability and place of manufacture

Each device is delivered with its declaration of conformity (Regulation (EU) 2017/745) stating the place of manufacture (France, or a qualified partner workshop in China — the piece being imported, checked and placed on the market by the Lab as manufacturer within the meaning of the Regulation). This enables the practitioner to fulfil their patient-information duty (French Public Health Code, art. L. 1111-3-2). Manufacturing records are kept for the statutory periods.

10. Personal data

The processing of personal data (practitioners and patients) is governed by the data processing agreement in Annex 1, which forms an integral part of these terms, and by the privacy policy.

11. Term, suspension and termination

The account is opened for an indefinite term, with no volume commitment. Either party may end the relationship at any time; pending orders are completed and paid. The Lab may suspend or close an account in case of serious breach (persistent non-payment, fraudulent use), after formal notice.

12. Governing law and disputes

These terms are governed by French law. The French version prevails over any translation. Failing amicable resolution, any dispute falls under the jurisdiction of the economic activities court of Châteauroux, France.

Annex 1 — Data Processing Agreement (GDPR art. 28)

A1.1 Roles

For patient data sent to the Lab (patient reference, clinical photos, impressions and scans, dictations and their transcripts, shades, messages): the Practice is the data controller and the Lab acts as processor, on the Practice's instructions as materialised by each order. The Lab is additionally a controller for its own legal obligations (custom-device traceability, accounting) and for practitioners' account data.

A1.2 Purpose and duration

Processing for the sole purposes of designing, manufacturing, checking, delivering and tracking the ordered devices, for the duration of the relationship, followed by retention of the manufacturing record for the statutory traceability periods, during which the data is no longer used for any other purpose.

A1.3 Authorised sub-processors

• MongoDB Atlas (database) and Amazon Web Services S3 (file storage);
• Vercel (application hosting);
• Deepgram (transcription of dictations and voice notes);
• Anthropic (structuring of dictations — no data used to train models);
• DeepL (translation of case threads);
• where applicable, the partner manufacturing workshop (international route), which only receives the technical elements needed for manufacturing (never the patient's full identity).

The Lab informs the Practice of any change of sub-processor; the Practice may object on legitimate grounds.

A1.4 Security

Encryption in transit (TLS), role-based access control, separated case threads, logging, EU storage for data at rest, automatic purge of files not attached to an order.

A1.5 Assistance and rights

The Lab assists the Practice in answering patients' data-subject requests (access, rectification, erasure within the limits of statutory traceability) and notifies any personal-data breach within the meaning of GDPR art. 33 without undue delay to the Practice's email address.

A1.6 Return and deletion

When the account is closed, the Practice's and practitioners' personal data is deleted (see account deletion); manufacturing records are retained, detached from the accounts, under the Lab's legal obligations.

Contact: contact@opaldentallab.fr — SIREN 107 246 142 — Route de Lignières, 36130 Déols, France.