Therms and Conditions


Last updated: 12 February 2026

These Terms and Conditions (“Terms”) form a binding agreement between you (“you”, “Client”, “Doctor”, “Dental Practice” or “Dental Practice Representative”) and Cristaline Aligners GmbH, acting under the Sigma Aligners brand (“Sigma Aligners”, “we”, “us”, “our”), governing your access to and use of the Sigma Aligners website and portal, and the services provided through them (collectively, the “Platform”).

By accessing or using the Platform you agree to be bound by these Terms and our Privacy Policy. If you do not agree, do not use the Platform.


1. Company details

Cristaline Aligners GmbH
Hanauer Straße 1–5, 75181 Pforzheim, Germany
VAT ID: DE301720631

Email: info@cristaline-aligners.net

Platform / Website: https://www.sigma-aligners.com

Portal (doctor account): http://sigma-aligners.com/en-us/user/sign-in/login

2. Eligibility and intended use

2.1. The Platform and Services are intended solely for licensed dental professionals, dental clinics and their authorised representatives, and authorised dealers (if applicable).

2.2. The Platform is not intended for patient self-service ordering. Any information on the Platform is for professional information purposes and does not create a doctor–patient relationship between Sigma Aligners and any patient.

2.3. You represent and warrant that:

  • you are legally entitled to practise dentistry (or represent a legally operating dental practice) in your jurisdiction;
  • you will comply with all applicable laws, including medical device and data protection laws (including GDPR);
  • you have obtained all required patient consents and/or legal bases for sharing patient data with us and for ordering custom-made aligners for that patient.

3. Definitions (key terms)

Account – your professional user account in the portal.
Case – a patient profile created by you, including submitted data and files.
Patient – your patient receiving treatment.
Treatment Plan – digital 3D treatment plan and staging proposal prepared based on submitted files.
Order – a request for production of custom-made aligners based on an approved Treatment Plan.
Product – custom-made clear aligners, retainers and included accessories produced under the approved Treatment Plan.


4. Scope of Services

We provide services enabling you to:

  • create and manage an Account;
  • upload Case data and files;
  • receive a 3D Treatment Plan proposal (as described below);
  • approve/refine the Treatment Plan (depending on package);
  • order and receive custom-made Products;
  • receive customer support relating to orders.

We may update the Platform and its features from time to time.


5. Order process and Treatment Plan

5.1. Case submission requirements

To request a Treatment Plan and place an Order, you must upload the required patient data and clinical materials, which may include:

  • Patient identification data: last name, first name, date of birth, gender
  • Intraoral scan files: upper/lower jaw and occlusion in STL format
  • Intraoral photos: frontal, right and left occlusion, upper and lower jaw
  • Radiology/diagnostic files as applicable: X-ray / OPG, TRG, CT
  • Face photos: front view and profile view (if applicable for planning)

You are solely responsible for ensuring the accuracy, completeness, legality and quality of all submitted data.

5.2. Treatment Plan timeline

Subject to sufficient and usable submitted data, we will provide a Treatment Plan within three (3) working days.

5.3. Approval

Production begins only after you approve the Treatment Plan (and payment is received). By approving the Treatment Plan, you confirm that it matches your clinical intent and that you accept production according to the approved plan.


6. Treatment packages (LIGHT / COMFORT / UNLIMITED)

All packages include:

  • case planning by a certified orthodontist team with 3D visualisation,
  • aligner manufacturing,
  • one set of retainers (included),
  • necessary patient accessories (as applicable),
  • delivery,
  • customer support.

6.1. LIGHT package

  • intended for simple cases
  • 1–19 aligners
  • 1 free Treatment Plan
  • 2 sets of caps for fixing nozzles
  • 1 set of retainers included
  • treatment duration: up to 5 months
  • mid-treatment adjustments not included

If a correction is needed during treatment: preparation of a new Treatment Plan is free of charge; however, manufacturing of aligners based on the new plan will be charged at €20 per aligner + €20 shipping.

6.2. COMFORT package

  • medium complexity cases
  • 20–40 aligners
  • 1 free Treatment Plan
  • 2 sets of caps for fixing nozzles
  • 1 set of retainers included
  • treatment duration: up to 12 months
  • mid-treatment adjustments not included

If a correction is needed during treatment: preparation of a new Treatment Plan is free of charge; however, manufacturing of aligners based on the new plan will be charged at €20 per aligner + €20 shipping.

6.3. UNLIMITED package

  • difficult/complex cases
  • 41+ aligners
  • unlimited number of Treatment Plans and adjustments
  • 2 sets of caps for fixing nozzles
  • 1 set of retainers included
  • treatment duration: more than 12 months
  • mid-treatment adjustments included, including refinements during treatment and certain replacements, as described below.

UNLIMITED includes: corrections at the planning stage, refinements during treatment, production of new aligners in case of breakage/deformation, production of single aligners in case of loss (subject to reasonable use and verification).

Additional retainers beyond the included set are available at €20 per retainer + shipping (€20).

6.4. Clarification

Package descriptions on the Platform form part of these Terms. If package details are updated, the version displayed at the time of Order governs that Order unless otherwise agreed in writing.


7. Pricing, payment and taxes

7.1. Prices are shown or communicated through the Platform or our support team. We may update pricing due to factors beyond our control.

7.2. Payment methods may include PayPal or bank transfer. Where the Platform requires contacting our team to select the payment method, you agree to follow the provided instructions.

7.3. You are responsible for any applicable taxes, duties and customs charges in your jurisdiction unless expressly stated otherwise.


8. Manufacturing and delivery

8.1. Manufacturing time: typically within ten (10) working days after Treatment Plan approval and payment, subject to production load and case complexity.

8.2. Shipping: orders are shipped from Germany via UPS, DHL or FedEx. We provide tracking details when available.

8.3. Worldwide shipping: included where stated on the Platform. Extra aligners/retainers (outside package inclusions) may incur additional shipping fees as described in the package terms.


9. No returns / defects and replacements

9.1. Due to the custom-made nature of aligners, returns are not accepted.

9.2. If you believe there is a manufacturing defect or issue attributable to production, you must notify us promptly with reasonable supporting evidence. We will assess and, where appropriate, provide a replacement at our discretion on a case-by-case basis.


10. Clinical responsibility and disclaimers

10.1. You remain solely responsible for diagnosis, treatment planning decisions, patient communication, monitoring, and clinical outcomes.

10.2. We do not verify whether submitted materials (scans/photos/X-rays) are clinically consistent or sufficient; we rely on the materials you provide.

10.3. Treatment outcomes cannot be guaranteed because patient compliance, biology, clinical factors and usage conditions are outside our control.

Nothing in these Terms limits liability that cannot be excluded under applicable law (including mandatory product liability rules).


11. Account security and acceptable use

11.1. You are responsible for keeping login credentials confidential and for all activities under your Account.

11.2. You must not:

  • introduce malware, attempt to bypass security, scrape data, or overload the Platform;
  • access other users’ data without authorisation;
  • use the Platform unlawfully or in a way that infringes rights of others.

We may suspend or terminate Accounts for violations.


12. Intellectual property

All Platform content, trademarks, designs and software remain our property or our licensors’ property. You receive a limited, non-transferable right to use the Platform for your professional use in accordance with these Terms.


13. Data protection

Personal data processing is governed by our Privacy Policy and, where applicable, data processing agreements with clinics/partners.

You warrant that you have obtained all necessary consents and legal bases for sharing patient data with us and that you comply with applicable confidentiality obligations.


14. Force majeure

We are not responsible for delays or failure in performance caused by events beyond our reasonable control, including but not limited to: courier delays, strikes, war, epidemics/pandemics, governmental actions, fire, communication failures, power outages, earthquakes, or other disasters.


15. Governing law and jurisdiction

These Terms are governed by the laws of the Federal Republic of Germany. Courts in Germany shall have jurisdiction, unless mandatory law provides otherwise.


16. Changes to these Terms

We may update these Terms by posting the revised version on the Platform. Continued use after changes take effect constitutes acceptance.


17. Contact

Questions regarding these Terms:
info@cristaline-aligners.net