Germany has the largest dental laboratory sector in Europe — and the highest cost base. We manufacture the aligners and produce the 3D setups so your Labor can offer a competitive aligner line without buying printers, thermoformers or a planning team.
A Dentallabor in Germany answers to the MPDG, to BfArM, and to its own QM system. The supplier question is never just price — it is whether the paperwork survives an audit.
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 by BfArM or your Landesbehörde.
Single Registration Number for the manufacturer and Authorised Representative, Basic UDI-DI assigned per device family, UDI carriers applied per the MDR timetable.
Instructions for use and patient-facing material supplied in German. Under the MPDG, information accompanying a device placed on the German market must be in German — an English-only IFU is a compliance gap, not a detail.
Design control, supplier qualification, process validation, batch traceability and CAPA. Batch records retained per case. Certificate and audit reports available under NDA for your supplier evaluation file.
Intraoral scans are Gesundheitsdaten under Article 9 GDPR. Auftragsverarbeitungsvertrag signed, encrypted transfer, pseudonymised case IDs, defined deletion schedule. Your practice or lab remains the controller.
Complete Lieferantendokumentation supplied on request before your first case.
Add an aligner line to your existing crown, bridge and prosthetics business. No capex, no new technicians, no software licence. You keep the practice relationship; we handle setup and production.
Keep aligner cases in-house instead of referring them out. Submit a TRIOS or Primescan file, approve the 3D plan, receive the course branded to your practice.
Launching your own aligner brand? 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 Germany | DDP express courier. Duties and customs settled at origin — nothing held at Zoll, no surprise invoice on delivery. | 6–8 days |
Invoicing in EUR. Import VAT position confirmed for your USt-IdNr 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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