Poland already exports dental work across Europe. If your laboratorium is competing on price and turnaround, the aligner line should not be the thing that eats your margin. We manufacture and plan; you keep the client and the brand.
Polish labs supplying clinics across the EU carry the paperwork risk down the chain. A supplier who cannot produce a technical file on request is a liability, not a bargain.
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 URPL.
Single Registration Number for manufacturer and Authorised Representative, Basic UDI-DI per device family, UDI carriers applied per the MDR timetable.
Instructions for use, wear schedules and patient care material supplied in Polish. Information accompanying a device on the Polish market must be in Polish.
Design control, supplier qualification, process validation, batch traceability and CAPA. Batch records retained per case. Certificate available for your supplier evaluation file.
Skany wewnątrzustne are dane o zdrowiu 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.
Add an aligner line without buying printers, thermoformers or planning software. Per-case pricing, no volume commitment, no idle capacity when the pipeline is thin.
Keep aligner cases in-house instead of referring them out. Submit a scan, approve the plan, receive the course branded to your clinic.
Full white label across packaging, portal and paperwork. Your logo on the box, ours nowhere.
| 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 Poland | DDP express courier. Duties and customs settled at origin — nothing held at the border, no surprise invoice. | 6–8 days |
Invoicing in EUR or PLN. Import VAT position confirmed for your NIP 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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