Spain has one of Europe s most consolidated dental markets — clinic groups and DSOs buying at volume, competing hard on price. We manufacture the aligners and produce the 3D setups so your clínica can hold its margin without holding the capex.
A clinic group buying aligners at volume will have its own compliance officer, and that person will ask for the technical file before they ask for a discount. Here is what we hand over.
Clear aligners are Class IIa devices. Technical documentation, clinical evaluation and post-market surveillance maintained to MDR requirements. Declaración de conformidad 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 AEMPS.
Instructions for use, wear schedules and patient care material supplied in Spanish. Information accompanying a device on the Spanish market must be in Spanish — an English-only IFU will not pass an inspection.
Single Registration Number for manufacturer and Authorised Representative, Basic UDI-DI per device family, UDI carriers applied per the MDR timetable.
Design control, supplier qualification, process validation, batch traceability and CAPA. Batch records retained per case. Certificate available for your homologación de proveedores file.
Escaneos intraorales are datos de salud under Article 9 GDPR. Data Processing Agreement signed, encrypted transfer, pseudonymised case IDs, defined deletion schedule. Your clinic remains the controller.
Full regulatory pack supplied on request before your first case.
Volume pricing that survives a procurement review. One supplier, one portal, one invoice across every location in the group.
Add an aligner line to your existing prosthetics business without capital expenditure. You keep the clinic relationship; we handle the setup and the manufacturing.
Full white label across packaging, portal and paperwork. Your logo on the box, ours nowhere — 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 Spain | DDP express courier. Duties and customs settled at origin — nothing held at aduana, no surprise invoice. | 6–9 days |
Invoicing in EUR. Import VAT position confirmed for your NIF/CIF before the first shipment. Canary Islands, Ceuta and Melilla handled separately — ask us.
Upload a scan, review the 3D setup within 48 hours, and decide from there. No minimum order, no annual commitment.
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