How Are Clear Aligners Manufactured? A Step-by-Step Guide

Table of Contents

1. How are clear aligners manufactured?
2. Can I make my own clear aligners? Here’s the reason why you shouldn’t
3. The Eon One Solution by Eon Dental
4. Quality assurance
5. Case of success
6. FAQs
7. Conclusion

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Clear aligners are fast becoming the preferred alternative to traditional metal braces and many companies are exploring providing clear aligners to patients under their own brand. Cear aligner manufacturing is a massive undertaking requiring many steps and quality control along the entire process. Although it is complicated, in short, clear aligners are made by molding plastic films via thermoforming on customized 3D-printed casts.

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How are clear aligners manufactured? A Step-by-step guide
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1. Digital treatment design

Before manufacturing clear aligners, a treatment plan is set up by experienced dental technicians, dentists, and orthodontists. The treatment plan shows how the patient’s teeth will move based on clinical validation by our medical team and teeth movement protocols.

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2. 3D printing

The provided treatment plans are translated to digital STL files that are then fed into 3D printing machines, which then print out solid 3D models.

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3. Thermoforming

Once the 3D printed models are produced using the steps above, the clear aligner material is thermoformed on the cast. The material used for clear aligners is a defining factor in the durability and efficacy of the clear aligners as well as ensuring the comfort of the clear aligner treatment.

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4. Laser marking

The thermoformed plastic is then laser marked for traceability and quality assurance purposes. 

5. Trimming & polishing

Once the thermoformed plastic is laser marked, it moves onto trimming and polishing. The automatic cutout and trimming of the clear aligner is done according to the requested specifications; depending on the requirements for either scalloped or straight cut trimlines. The clear aligners are then polished to ensure a smooth surface for comfortable wear. 

6. Quality check

By far the most important step in the manufacturing process, and one that differentiates manufacturers from their competitors, is quality check. A thorough inspection is  carried out to ensure that the clear aligners have zero defects.

7. Packaging & shipping 

The clear aligners are sorted and packaged into customized boxes for each individual customer. The clear aligners are packaged in two types of packaging; primary and secondary. Primary packaging includes the inner clear aligner packet, whereas the secondary packaging includes a box, usually containing several elements of a branded clear aligner kit such as the clear aligner trays, chewies (or aligner seaters) and a clear aligner removal tool.

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Can I make my own clear aligners? Here’s the reason why you shouldn’t

As a brand, manufacturing your own clear aligners is possible, albeit difficult. It includes hundreds of thousands of dollars in upfront investments in production, a challenging process of registering your product with official authorities, which costs another few hundred thousand dollars, large efforts and investments in creating and implementing a compliant software infrastructure, in addition to the complexity of complying with all the legal manufacturing requirements for clear aligner production as a custom-made orthodontic appliance. Additionally, the set up time for the operations consumes many months if not more. For those reasons, many companies interested in distributing clear aligners search for white-label clear aligner manufacturers, like Eon Dental that provide market-ready turnkey solutions through the Eon One solution.

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The Eon One Solution by Eon Dental

At Eon Dental, we pride ourselves on providing a comprehensive solution for all your clear aligner needs. Our white label solution, Eon One, allows businesses to fully customize their clear aligner brand to meet their specific needs.

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Manufacturing and Packaging

‍Our state-of-the-art manufacturing facility is equipped with proprietary cutting-edge technology and operated by skilled experts who ensure precision and quality at every step of the production process. We employ advanced techniques to create clear aligners that fit perfectly and deliver exceptional results. Additionally, our packaging services go beyond functionality – we offer unbranded packaging and customizable branded packaging options that reflect your brand's identity, leaving a lasting impression on your doctors and patients.

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Software

Our white-label software solutions, the partner portal and the doctor portal, provide easy and efficient ways to manage patient cases and track treatment progress. This allows you to streamline your workflow and provide doctors a better experience with your brand.

Clinical Services

But we don't stop there. Our orthodontist-led clinical team is here to provide expert support and guidance every step of the way. With decades of experience, our team creates effective treatment plans for mild, moderate, and complex cases with low refinement rates and 2-4% adjustment rates. This ensures that your doctors receive the best possible care in the market.

Additional Premium Services

‍Our support to you as an Eon Dental client also extends into the realm of commercial and marketing support. The Eon One solution by Eon Dental offers comprehensive commercial guidance with pricing, RevOps and go-to-market strategies in addition to marketing materials and kits to support marketing your product, strategies and custom branding services.  If you’re thinking of launching your own brand or growing an existing brand, Eon Dental’s services can be tailored to the needs of your business.

In summary, Eon Dental is committed to providing comprehensive and customizable solutions for starting or growing a clear aligner brand. From manufacturing, packaging, shipping, software solutions, treatment planning, clinical support, commercial and marketing support, we have you covered.

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Quality assurance of clear aligners

At Eon Dental, we understand the importance of providing our customers with clear aligners of the highest quality. We have an ISO 13485:2016 certified quality management system that sets in place processes and procedures to ensure the quality of the clear aligner is assured at every stage of manufacturing.  We believe that through our rigorous quality assurance process, we are able to provide our customers with clear aligners that they can trust to be effective and safe. It is our commitment to quality that sets us apart as a leading white label manufacturing company. 

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A case of success

In 2020, an Eon Dental Client, whose name is reserved for confidentiality purposes, wanted to expand their business by venturing into the burgeoning clear aligner market. However, the rigorous 510(k) clearance process and the hefty up-front investment needed presented a major roadblock, which could result in significant investment and delay their go-to-market strategy.

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To find a solution, the client reached out to us at Eon Dental, referred to us by one of our suppliers, who was impressed by Eon One, Eon Dental’s white-label solution. Our low-risk model allowed the client to plug their brand into everything from software to unique packaging that truly represented who they are. The partnership enabled the client to avoid building clinical expertise and competencies from scratch, which was both cost and time effective.

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The client’s decision to work with us was heavily influenced by our team's people-centric approach, which made them feel comfortable and confident in the partnership. Eon Dental’s packaging and execution were also superior to other partners, according to the client.

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Moreover, the client learned that doctors needed support in getting started with clear aligners, including which cases to start with, how to build up clinical confidence, and how to introduce them to patients. At Eon Dental, we were able to provide the client with the necessary guidance and support to overcome this challenge.

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Ultimately, the client was able to successfully expand their business into the clear aligner market with us as their partner, saving time, money, and avoiding potential roadblocks that could have impeded their progress.

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*Names have been removed for client confidentiality purposes, however this is a factual case use study and testimonial

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FAQs

How are clear aligners printed?

Digital scans of the patient's teeth are used to generate a sequence of 3D virtual files that move the patient’s teeth, which are afterwards 3D printed to form molds. Clear aligners are then created by thermoforming thermoplastic films onto these molds.The clear aligner is then polished, cleaned, quality checked, and packaged. 

Can you make clear aligners with a 3D printer?

3D printers are an integral part of the clear aligner manufacturing process, however the clear aligners themselves are not 3D printed. Resin molds of the patient’s teeth are printed using a 3D printer, after which thermoplastic polyurethane films are thermoformed onto the resin casts to make the clear aligners.

How long does it take to make clear aligners? 

Making clear aligners is a fast process, however there are treatment planning processes before manufacturing as well as shipping factors after manufacturing that influence how long it will take to receive your clear aligners. At Eon Dental, we pride ourselves on our fast turnaround time. Once STL files are sent to our clinical team, you can expect to have your treatment plan within 72 hours. Once that is approved, your clear aligners should be delivered within 10 days. 

How to make clear aligners more comfortable?

It is important to note that just like any other orthodontic treatment there are common side effects of using clear aligners such as: tooth and jaw soreness, irritation of the lips, gums, and tongue, mild speech changes such as a lisp, bad breath or dry mouth. In order to make clear aligners that are comfortable for your patient, several things should be taken into consideration during the manufacturing process;  such as the quality of the clear aligner material, trim lines (scalloped vs straight) and initial insertion force.

Conclusion

‍Manufacturing clear aligners involves a series of well-defined steps, from digital treatment design to quality checks and packaging. While producing your own clear aligners presents challenges and significant investments, choosing a partner like Eon Dental that offers a comprehensive solution that covers software, clinical support, manufacturing, packaging and commercial and marketing enablement. Our commitment to quality and customer-centric approach positions us as a leading provider in the industry. Choose Eon Dental to embark on a successful journey of establishing or growing your clear aligner brand.

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