Add an aligner line to your practice or laboratory without buying a printer, a thermoformer or a planning team. We manufacture, you brand it. MHRA-registered route, UK Responsible Person appointed, GBP invoicing, DDP delivery in 5–7 days.
Great Britain left the EU medical device framework. England, Scotland and Wales run on UK MDR 2002 as amended, administered by the MHRA. Northern Ireland still follows the EU rules. A supplier who only talks about CE marking has not done the homework.
Clear aligners are Class IIa devices. Devices placed on the Great Britain market must be registered with the MHRA. We hold that registration and can supply the registration evidence your practice or lab needs for its own records.
A manufacturer based outside the UK must appoint a UK Responsible Person before placing devices on the GB market. Ours is appointed and named in the technical file — the MHRA can contact them directly.
Great Britain currently accepts both CE-marked and UKCA-marked devices under the extended recognition arrangements. Northern Ireland continues under CE. We supply against whichever route applies to where you are.
Design control, supplier qualification, process validation, batch traceability and CAPA. Batch records retained per case. Audit reports available under NDA.
Intraoral scans are special-category health data. We sign a Data Processing Agreement, transfer over encrypted channels, work from pseudonymised case IDs and delete on a defined schedule. Your practice stays the controller.
Every aligner case must be prescribed and supervised by a GDC-registered dentist. We manufacture to your prescription — we do not treat patients, and we never bypass the clinician.
Full documentation pack — declaration of conformity, ISO 13485 certificate, material safety data sheets and Responsible Person details — supplied before your first case.
Add clear aligners to your crown-and-bridge or denture business without capital expenditure. You keep the client relationship, we do the setup and the manufacturing. Per-case pricing, no volume commitment.
Keep aligner cases in-house instead of referring them out. Submit an iTero or TRIOS scan, approve the 3D plan, receive the full course branded to your practice.
Launching a direct-to-consumer or clinic-led aligner brand? Full white label across packaging, portal and paperwork. Your patients never see our 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 UK | DDP express courier. Duties and customs settled at origin — nothing held at the border, no surprise invoice. | 5–7 days |
Invoicing in GBP. VAT treatment confirmed for your registration 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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