Europe · OEM & Private Label

Clear aligner manufacturing, built for Europe

Clear Moves Aligners is an OEM and private-label clear aligner manufacturer for European dental labs, clinics and aligner brands. Digital treatment planning, medical-grade multilayer material, and a regulatory file your compliance team can actually read.

150,000+Aligners delivered
30+Countries served
48 hrs3D setup turnaround
ISO 13485Certified QMS
Patient wearing clear aligners manufactured by Clear Moves Aligners for a European dental practice

Issued before case one

  • CE mark, EU MDR 2017/745
  • EU Authorised Representative
  • ISO 13485 certificate
  • Signed GDPR data agreement

Certifications held by Clear Moves Aligners

CE marking EU MDR 2017/745 ISO 13485 certified quality management system MHRA registered United Kingdom FDA 510k cleared K241137 TGA certified Australia
Regulatory

The compliance file, before the sales pitch

Placing a Class IIa device on the EU market is a documentation problem before it is a manufacturing one. Every document below is issued to you in the regulatory pack before your first case — not promised and then chased.

MDR 2017/745

CE marking under EU MDR

Clear aligners are Class IIa medical devices in the EU. Technical documentation, clinical evaluation and post-market surveillance are maintained to MDR requirements. The declaration of conformity and notified body reference are issued with your regulatory pack.

Article 11

EU Authorised Representative

Under MDR Article 11, a manufacturer established outside the Union cannot place devices on the EU market without an appointed Authorised Representative. Our AR details are supplied in the regulatory pack — and you should ask the same of every non-EU supplier you evaluate.

EUDAMED & UDI

Device registration & traceability

Registration in the European database on medical devices, with the Single Registration Number and Basic UDI-DI for the relevant device family provided on request for your own supplier records.

UKCA & MHRA

The separate UK regime

Great Britain is a separate regime post-Brexit, administered by the MHRA rather than under CE. Northern Ireland continues under the EU rules. We supply against whichever route applies to where you are — the paperwork is not interchangeable.

ISO 13485

Quality management system

Full QMS covering design control, supplier qualification, process validation, traceability and CAPA. Batch records retained per case. Certificate and audit reports available under NDA to qualified partners.

GDPR Article 9

Intraoral scan data

STL files and patient records are special-category health data. We provide a signed Data Processing Agreement, defined retention windows, encrypted transfer and pseudonymised case IDs — so your clinic stays the controller and we stay the processor.

Regulatory pack, declaration of conformity, ISO certificate and material safety data sheets supplied on request before your first case.

Lead times

Scan to doorstep, in days not weeks

Working days from the moment your STL lands in our portal. Shipping is DDP by default — duties and customs handled at origin, so nothing gets held at your border.

01

Scan received

STL or PLY uploaded to the doctor portal. Case reviewed for clinical viability and file quality.

Same day
02

3D treatment setup

Digital setup produced — staging, attachments and IPR mapped movement by movement.

24–48 hrs
03

Your approval

You review the plan in the portal, request modifications, approve. Unlimited revisions before production.

Your call
04

Production & QC

Thermoforming on medical-grade multilayer sheet, trimming, polishing, batch QC, packaging.

2–3 days
05

Dispatch to EU

DDP express courier from origin. Tracked. Customs and duties settled before it reaches you.

3–5 days
7–11 working days, end to end

From approved plan to a box on the practice desk. DDP means no customs invoice on arrival.

Send your first scan
IDS Cologne

Where many of our European partnerships began

We exhibited at the International Dental Show in Cologne in March 2025. Over five days we met laboratories, distributors and aligner brands from across Europe — and much of what you see on this page, from EU-specific documentation to DDP delivery, came directly out of those conversations.

We would rather begin a partnership across a table than a contact form.

2,000Exhibitors
from 60 countries
135,000Visitors
from 156 countries
5 daysKoelnmesse
March 2025
Clear Moves Aligners team at the IDS Cologne 2025 dental trade fair in Germany
Clear Moves Aligners stand at IDS Cologne 2025
Meeting European dental laboratory partners at IDS Cologne 2025
Clear aligners on display at IDS Cologne 2025 in Germany
Clear Moves Aligners at the International Dental Show, Cologne
March 2025

We exhibited

Five days at Koelnmesse meeting European labs, distributors and aligner brands face to face.

Between shows

Sample cases, on request

A physical sample case to your lab, or a video walkthrough of the facility — whichever tells you more.

16–20 March 2027

IDS returns to Cologne

We will be there again. If you would rather assess us in person, put it in the diary now.

Do not wait until 2027 to judge the aligners. Send us one scan, or ask for a sample case — the material, the trim and the packaging speak for themselves.

Request a sample case
Capabilities

What European partners buy from us

Four ways labs, clinics and brands work with us. Most start with one and add the others.

OEM

OEM aligner manufacturing

You send the case, we manufacture. Unbranded or branded, no minimum order, per-case pricing. Ideal for labs adding an aligner line without capital expenditure on printers and thermoformers. OEM details →

White label

Private label & white label

Your logo on the pouch, the box, the case and the packaging. Your treatment plan PDF, your portal branding. Your patients never see our name. White label →

Planning

Digital treatment planning

Outsourced 3D setups by trained technicians with orthodontist oversight. Attachments, IPR, staging and overcorrection specified. Delivered in 24–48 hours. Treatment planning →

Aftercare

Retainers & refinements

Post-treatment retainers on the same file, refinement rounds from a fresh scan, and a defined remake policy so a failed case does not become a margin problem. Treatable cases →

Private label

Your brand on the box. Ours nowhere.

European aligner brands do not want a supplier logo in the patient’s hands. Everything that leaves our facility can carry your identity end to end — packaging, print, portal and paperwork.

  • Branded outer box, aligner pouches and retainer cases
  • Your logo and colours on the patient treatment plan PDF
  • White-labelled doctor portal for case submission
  • Custom insert cards, wear schedules and care instructions
  • Neutral shipping documents — no third-party branding in the chain
Private label clear aligner packaging for European brands
3D clear aligner treatment planning software used for European cases
Compatibility

We take the scanner you already own

No proprietary hardware, no locked ecosystem, no conversion fee. If it exports an STL, we can plan it.

iTero Element / 5D 3Shape TRIOS Medit i500 / i700 Dentsply Primescan CEREC Omnicam Carestream CS 3600
STL PLY OBJ PVS impressions accepted
Comparison

Why not just use a local EU lab?

Sometimes you should. Here is the honest version of the trade-off.

Typical local EU aligner labClear Moves Aligners
Per-case costHighest cost base in the market — EU labour and facility overhead priced into every caseSubstantially lower, with the same medical-grade material and QMS
Regulatory routeCE marked, EU-established manufacturerCE marked under MDR, with Authorised Representative and EUDAMED details issued in the regulatory pack
Lead timeShorter transit, but planning queues are often longer3–5 days DDP express — the transit gap is days, not weeks
Treatment planningFrequently outsourced anyway, often offshoreIn-house planning team, 24–48 hr setups, unlimited pre-production revisions
Minimum orderFrequent volume commitments or annual contractsNo minimum — start with a single case
Private labelLimited; many will not white-label at allFull white label across packaging, portal and paperwork
FAQ

What European buyers ask us

The questions that come up in almost every first call with a lab or brand.

Who is the legal manufacturer under EU MDR?
Clear Moves Aligners is the legal manufacturer and holds the technical documentation, clinical evaluation and declaration of conformity. If you private-label our devices under your own brand and place them on the market as your own, MDR Article 16 obligations may transfer to you — we will walk your regulatory lead through exactly which arrangement applies before your first order.
What about the EU Authorised Representative?
Under MDR Article 11, no manufacturer established outside the Union can lawfully place a device on the EU market without an appointed Authorised Representative, named on the label and contactable by any competent authority. Our AR details are issued as part of the regulatory pack, and we are happy to share them at the evaluation stage.
Can we meet you in person?
We would welcome it. We exhibited at IDS Cologne in March 2025 and will be there again in 2027. In between, we can arrange a video walkthrough of the facility, send a physical sample case to your lab, or meet you at a regional dental exhibition.
Where is patient scan data processed and stored?
Intraoral scans and case records are special-category health data under GDPR Article 9. We sign a Data Processing Agreement, transfer files over encrypted channels, work from pseudonymised case IDs, and delete records on a defined retention schedule. Your clinic remains the data controller; we act strictly as processor on your documented instructions.
Who handles customs, duties and VAT?
We ship DDP by default: duties and customs clearance are settled at origin, so nothing is held at your border and there is no surprise invoice on delivery. Import VAT treatment depends on your member state and VAT registration — we confirm the position for your country before the first shipment.
What is the remake and refinement policy?
If an aligner fails to fit because of a manufacturing or planning defect on our side, it is remade at no cost. Refinements arising from patient non-compliance or a new clinical decision are quoted separately at a reduced rate. The policy is written into the partner agreement rather than left to goodwill.
Is there a minimum order?
No. You can send a single case to evaluate the setup quality, the material, the packaging and the turnaround before committing to anything. Volume pricing exists but it is not a gate.
How do you protect our intellectual property and case data?
Mutual NDA before any file is exchanged. Your case library, patient data and brand assets are never used in our marketing, never shown to other partners and never resold. Private-label partners appear nowhere on our website or client lists without written consent.
Start here

Send one case. Judge us on it.

No minimum order, no annual commitment. Upload a scan, review the 3D setup within 48 hours, and decide from there.

Start your first European case

Regulatory pack issued before case one · DDP shipping · No minimum order