Italy has more private-label aligner brands per capita than almost anywhere in Europe. If you are building one — or supplying the studi dentistici that sell them — we manufacture and plan; you own the brand, the patient and the margin.
This matters more in Italy than anywhere, because so many partners here white-label. Putting your name on a Class IIa device is not a marketing decision — it can make you the legal manufacturer. Read this section before you read the price list.
Clear aligners are Class IIa devices. Technical documentation, clinical evaluation and post-market surveillance maintained to MDR requirements. Dichiarazione di conformità 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 the Ministero della Salute.
If you place devices on the market under your own name, MDR Article 16 obligations may transfer to you — including your own quality system. We map the arrangement with your regulatory adviser before the first order, not after launch.
Instructions for use, wear schedules and patient care material supplied in Italian. Information accompanying a device on the Italian market must be in Italian.
Design control, supplier qualification, process validation, batch traceability and CAPA. Batch records retained per case. Certificate available under NDA for your supplier file.
Scansioni intraorali are dati sanitari under Article 9 GDPR. Data Processing Agreement signed, encrypted transfer, pseudonymised case IDs, defined deletion schedule. Your studio remains the controller.
Full regulatory pack supplied on request before your first case.
Full white label across packaging, portal and paperwork. Branded outer box, pouches, retainer cases, treatment plan PDF in your colours. Your patients never see a supplier name.
Add an aligner line to your existing prosthetics business without buying printers, thermoformers or planning software. You keep the studio relationship.
Keep aligner cases in-house instead of referring out. Submit a TRIOS or iTero file, approve the plan, receive the course branded to your practice.
| 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 Italy | DDP express courier. Duties and customs settled at origin — nothing held at dogana, no surprise invoice. | 6–9 days |
Invoicing in EUR. Import VAT position confirmed for your partita IVA 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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