Dutch practices went digital early — most already own the scanner. What is missing is the planning capacity and the manufacturing. We supply both, on a per-case basis, with a doctor portal your team can actually use.
Dutch buyers tend to ask short, direct questions and expect short, direct answers. Here they are.
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 IGJ.
Single Registration Number for manufacturer and Authorised Representative, Basic UDI-DI per device family, UDI carriers applied per the MDR timetable.
Instructions for use and patient material supplied in Dutch. Technical and regulatory documents supplied in English, which most Dutch practices prefer for the compliance file.
Design control, supplier qualification, process validation, batch traceability and CAPA. Batch records retained per case. Certificate available for your supplier assessment.
Intraorale scans are gezondheidsgegevens under Article 9 GDPR. Verwerkersovereenkomst signed, encrypted transfer, pseudonymised case IDs, defined deletion schedule. Your practice remains the controller.
Full regulatory pack supplied on request before your first case.
Keep aligner cases in-house rather than referring out. Submit a TRIOS or Primescan file, approve the 3D plan, receive the course branded to your practice.
Add an aligner line without buying printers, thermoformers or planning software. You keep the practice relationship; we handle setup and production.
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 NL | DDP express courier. Duties and customs settled at origin — nothing held at douane, no surprise invoice. | 5–7 days |
Invoicing in EUR. Import VAT position confirmed for your BTW-nummer 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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