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, relines, accessories). They are accepted when the account is created (time-stamped acceptance) and prevail over any other document, unless otherwise agreed in writing. Any new version is announced in the client portal and applies to orders placed after its update date.

2. Account, 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.

• The Lab accepts digital impressions from any intraoral scanner (STL, PLY or OBJ files, or direct submission from the manufacturers' platforms) as well as physical impressions. No equipment is imposed on the Practice and no equipment is conditional on an order volume.
• The Practice remains the owner of its impressions, scans and photos; the Lab uses them only for the purposes of the order and returns them on request.

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 and excluding VAT where applicable. 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.

• Prices include delivery within mainland France, whichever manufacturing route is used. For the international route, import duties, taxes and formalities are borne by the Lab: no charge is passed on to the Practice.
• The urgent option, where offered, carries a 50% surcharge on the price of the pieces concerned; the surcharge is displayed before the order is confirmed.
• Complex cases (full-arch rehabilitations, multiple implant work) may be subject to a prior quote, which then prevails over the price list.

4. Lead times and delivery

The estimated delivery date is computed in working days from receipt of usable elements and, where applicable, from approval of the 3D design (section 5). It takes into account the chosen route (Déols workshop or partner workshop), the number of pieces, French public holidays and the partner workshop's closures, shown in the client portal calendar. The displayed lead time is a best-effort commitment; the Lab informs the Practice without delay, in the case thread, of any event likely to shift it and proposes a new date.

• Where the delay is attributable to the Lab, any urgent surcharge invoiced is refunded.
• Parts travel at the Lab's risk until handed over to the Practice (delivery by the Lab or by tracked carrier). Risk transfers upon that handover.
• A failed delivery attributable to the Practice (practice closed during stated hours, wrong address) results in a new delivery attempt; the Lab is not liable for the resulting delay.

5. Quality control and approvals

Each case follows a control loop whose steps are notified to the practitioner in the app. Approvals given through the app constitute approval for manufacturing or for shipping and are binding.

• 3D design. The design is submitted to the practitioner before manufacturing. Absent a response within the deadline shown with the notification (six working hours, Monday to Friday, 8 am to 6 pm Paris time), the design is deemed approved and manufacturing starts. A reasoned rejection in the case thread leads to a new proposal at no charge, provided it stays within the prescription.
• Finished-work photos. No piece ships without control photos submitted to the practitioner. Absent a response within one working day, shipping is deemed authorised. A reasoned rejection leads to correction or remake before shipping.
• Changes requested after approval of the design or the photos constitute a new service, invoiced according to the price list unless the non-conformity is attributable to the Lab.

6. Receipt, claims and returns

• The Practice checks the parcel on receipt and reports any transport damage within three working days through the app, with photos.
• Any non-conformity found (fit, contact points, occlusion, shade, surface finish) is reported through the app within eight working days of receipt or, if later, at the first fitting appointment. The report describes the defect and attaches the relevant photos; the Lab answers in the case thread within one working day.
• Pieces to be adjusted or remade are returned in their original packaging with the label provided by the Lab. Return and re-shipping costs are borne by the Lab where the non-conformity is attributable to it. Adjustments and remakes are handled as a priority.
• After these periods, pieces are deemed accepted, without prejudice to the warranty in section 9.

7. Payment

Unless otherwise agreed, invoices are issued monthly and payable within 30 days of issue, by bank transfer, with no discount for early payment. 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. For a new account or after a payment incident, the Lab may require a deposit or payment on order.

8. Retention of title

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

9. 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, temporaries, repairs and relines for 1 month, from delivery. In case of proven non-conformity, the Lab remakes or adjusts the piece free of charge, upon its return. The warranty covers the remake or adjustment of the device, excluding fitting fees and costs.

• The warranty assumes fitting within three months of delivery; beyond that, the Lab may ask for a prior check of the piece.
• Excluded: defects attributable to the impression, scan or prescription; changes requested after approval of the 3D design or the photos; adjustments or repairs carried out by a third party; undisclosed bruxism, drops, poor hygiene or maintenance; the consequences of fitting or cementation not in line with the material manufacturer's recommendations.
• The practitioner's approval of the 3D design and of the finished-work photos through the app constitutes approval for manufacturing and for shipping and is binding.

10. Changing or cancelling an order

An order may be changed or cancelled free of charge through the app as long as the 3D design has not been approved and manufacturing has not started (“milling” or “finishing” status). Beyond that point, cancellation entails invoicing of the work performed and materials committed, up to the price of the order.

11. Materials, conformity and traceability

The materials used (zirconia, ceramics, alloys, resins, denture teeth) are CE-marked and traced by batch; their certificates are provided on request. 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) and verifiable online by its number. This enables the practitioner to fulfil their patient-information duty (French Public Health Code, art. L. 1111-3-2). Manufacturing records are kept for at least ten years, and fifteen years for implantable devices.

12. 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.

13. Force majeure

Neither party is liable for a failure caused by an event beyond its control within the meaning of article 1218 of the French Civil Code, including interruption of transport or air links, customs blockage, power or network outage, epidemic, external strike or administrative decision. Lead times are suspended for the duration of the event; the Lab informs the Practice and proposes, where possible, manufacturing through another route.

14. Intellectual property and files

Design files (CAD) produced by the Lab remain its property. For continuity of care, a copy of the design files for a case is provided to the Practice on request, for that case only. The trademarks, interfaces and content of the app and client portal are the property of the Lab.

15. 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.

16. Term, suspension and termination

The account is opened for an indefinite term, with no exclusivity and 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.

17. 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, notwithstanding multiple defendants or third-party claims.

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.