Orthodontic aligner cases without the capital outlay. We produce the 3D treatment setups and manufacture the aligners; your cabinet or laboratoire keeps the patient relationship, the prescription and the margin. CE-marked under MDR, French-language documentation, DDP delivery in 6–8 days.






Two things trip up aligner suppliers entering the French market: documentation that is not in French, and any suggestion that a patient can be treated without a chirurgien-dentiste. We do neither.
Clear aligners are Class IIa devices. Technical documentation, clinical evaluation and post-market surveillance maintained to MDR requirements. Declaration of conformity supplied with the first order.
Under MDR Article 11, a manufacturer outside the Union cannot place devices on the EU market without an appointed Authorised Representative — named on the label and reachable directly by the ANSM.
Instructions for use, wear schedules and patient care material supplied in French. Information accompanying a device placed on the French market must be in French — an English-only IFU is a compliance gap.
Aligner treatment in France is prescribed and supervised by a chirurgien-dentiste or an orthodontiste. We manufacture to your prescription. We do not treat patients and we do not sell around the practitioner.
Design control, supplier qualification, process validation, batch traceability and CAPA. Batch records retained per case. Certificate available for your supplier evaluation file.
Empreintes numériques are données de santé under Article 9 GDPR. Data Processing Agreement signed, encrypted transfer, pseudonymised case IDs, defined deletion schedule. Your cabinet remains the controller.
Full regulatory pack supplied on request before your first case.
Keep aligner cases in-house rather than referring them out. Submit a TRIOS or Primescan file, approve the 3D plan, receive the full course branded to your practice.
Add an aligner line to your existing prosthetics business without capital expenditure. You keep the practice relationship; we handle the setup and the manufacturing.
Full white label across packaging, portal and paperwork. Your logo on the box, ours nowhere — your patients never see a supplier name.
| Stage | What happens | Time |
|---|---|---|
| 1. Scan received | STL or PLY uploaded to the doctor portal. Reviewed for clinical viability and file quality. | Same day |
| 2. 3D treatment setup | Digital setup produced — staging, attachments and IPR mapped movement by movement. | 24–48 hrs |
| 3. Your approval | Review in the portal, request modifications, approve. Unlimited revisions before production. | Your call |
| 4. Production and QC | Thermoforming on medical-grade multilayer sheet, trimming, polishing, batch QC, packaging. | 2–3 days |
| 5. Dispatch to France | DDP express courier. Duties and customs settled at origin — nothing held at the douane, no surprise invoice. | 6–8 days |
Invoicing in EUR. Import VAT position confirmed for your numéro de TVA before the first shipment.
Upload a scan, review the 3D setup within 48 hours, and decide from there. No minimum order, no annual commitment.
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