AlignerHub connects dental practices, labs, and entrepreneurs with ex-Invisalign and ex-ClearCorrect treatment planning and ISO-13485 certified, FDA-approved aligner manufacturing — without the overhead of building it yourself.
If you're a dental practice, dental lab, or an entrepreneur who wants to start or grow an aligner business — without upfront or ongoing investment in hiring, training, treatment-planning software licenses, or expensive 3D scanners and printers — AlignerHub was built for you.
Every treatment planning provider on our team — dentists and dental technicians alike — has worked at Invisalign or ClearCorrect for at least 10 years, using the same cutting-edge 3D treatment planning software and tools.
We don't just check for a certificate — every manufacturing partner goes through multiple rounds of trials before joining our platform.
Minimum operating history required to join our manufacturing network.
Established, adequately staffed production facilities only.
Minimum production capacity to ensure reliable turnaround at scale.
Every manufacturer demonstrates product quality by producing for our own patients first.
Every manufacturing partner in our network is required to hold multi-region regulatory certification — not just a single quality badge.
US clearance for clear aligner manufacturing, meeting FDA requirements for medical device safety and effectiveness.
Certifies the entire quality management system — not a single batch — covering document control, risk management, and traceability.
Confirms conformity with EU health, safety, and environmental protection standards for medical devices.
Compliance with the EU's Medical Device Regulation, the current, more stringent standard for devices sold in Europe.
Registered with the UK's Medicines and Healthcare products Regulatory Agency for legal sale in the UK market.
Approved by Australia's Therapeutic Goods Administration, enabling legal sale and distribution in the Australian market.
Every aligner is also manufactured using FDA-approved materials as a baseline requirement, on top of full facility-level certification.
Want the full breakdown? ISO 13485 Explained → · Essix vs. Zendura Materials →
The clear aligner market has seen significant growth in recent years, driven by increasing demand for aesthetic solutions to malocclusion — a trend expected to accelerate further with advancements in AI, machine learning, cloud-based treatment tools, and telehealth.
An expanding adult population seeking orthodontic treatment, along with new markets emerging across Asia-Pacific and Latin America, means the industry is positioned for continued expansion worldwide — and there's still room for practices and entrepreneurs to get in early.
Your first treatment plan and first set of aligners are free — see the quality and experience behind AlignerHub for yourself.
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