Align Technology, Inc. (NASDAQ: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign System of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, today announced the addition of restorative capabilities to its next-generation iTero Lumina intraoral scanner (without iTero Near Infra-Red Imaging (NIRI) technology) and the new iTero Lumina Pro dental imaging system (with iTero NIRI technology). These additions will enable efficient restorative and multidisciplinary ortho-restorative workflows and support the diagnosis of interproximal caries above the gingiva, helping GP dentists reach new levels of practice efficiency and growth while delivering exceptional clinical outcomes.
Initially launched in February 2024, the iTero Lumina intraoral scanner delivers faster scanning speed, higher accuracy, superior visualization, and a more comfortable scanning experience.
The enhanced capabilities of the iTero Lumina solutions provide an outstanding scanning experience and performance, optimal for the simplest to the most challenging restorative cases. These capabilities are complemented by simplified restorative workflows that include the capture of single-unit dental crowns to full dental arches with multiple preparations in a single pass, with a wave of an iTero Lumina wand.
Practice Efficiency and Growth: Effortless scanning experience and optimized workflows that simplify patient record taking and minimize chair time and footprint.
Capture simple to complex cases and extraoral appliances and materials in one uninterrupted movement, without the need to scan each individual preparation from multiple preparation cases.
Experience versatility and efficiency with up to five capabilities in one device for less footprint in the practice, designed to reduce maintenance time and costs and enable the full automation of daily tasks from scanning to patient communication and lab collaboration:
- Photorealistic 3D models,
- HD intraoral camera,
- Aid in interproximal caries detection with NIRI technology,
- Photorealistic scans that eliminate the need for intraoral photos for Invisalign case submission,
- Scans that are within comparable thresholds of photogrammetry, all in one single scan.
Simplify multiple treatment planning by using previous patient scans for all procedures within the treatment plan. There is no need to re-scan the patient and add chair time to your workflow.
Exceptional Clinical Outcomes: Superior clinical accuracy.
Achieve predictable and repeatable first-time restoration fit from single-unit crowns to removable prosthetics, thanks to superior full-jaw accuracy compared to tested intraoral scanners and scans that are within accuracy thresholds of photogrammetry for full-arch implant restorations—the highest standard for prosthetic planning captured in one single scan.
Provide comprehensive patient data to your lab at once, including multi-bite and articulation information, to enable the design of optimal restorations and appliances.
Elevated Staff and Patient Experience: Offer a quick and comfortable experience for patients.
Increase patient engagement and understanding with a modern and customized experience based on patient-centric views of their oral health condition.
“We are excited to announce that the upgraded iTero Lumina scanner and new iTero Lumina Pro dental imaging system can now help doctors deliver exceptional restorative outcomes with the wave of a wand,” said Karim Boussebaa, Align Technology executive vice president and managing director for the iTero scanner and services business. “The iTero Lumina solutions include superior 3D and 2D visualizations to augment and amplify oral health assessment and communication using the Align Oral Health Suite, designed to increase patient engagement and understanding of their oral health condition.”
Dr. Karla Soto, GP dentist and Align Faculty member with a practice in Boca Raton, Florida, added, “The iTero Lumina scanner excels in the traditionally challenging scans with long spans, like full arch implant restorations or even edentulous areas. The amount of data and tissue it can capture is outstanding, making what was once a challenge, an easy, fast, and comfortable procedure for me, my team, and my patients.”
Current iTero Lumina scanner owners will receive the new software, which includes restorative and diagnostic support capabilities (without iTero NIRI technology), starting in April via direct software update, following regulatory clearance in their countries.
The iTero Lumina Pro dental imaging system in cart and mobile configurations is commercially available in the United States, Canada, Australia, New Zealand, Japan, Hong Kong, Singapore, and Vietnam.
The iTero Lumina scanner cart and mobile configuration is commercially available in the United States, Canada, European Union countries, the United Kingdom, Northern Ireland, South Africa, Kenya, Ghana, Australia, New Zealand, Japan, Hong Kong, India, Singapore, Vietnam, Korea, Taiwan, and Thailand.
The iTero Lumina scanner and iTero Lumina Pro dental imaging system are expected to be available pending regulatory approvals in other locations throughout 2025. Please contact your sales rep to find out when iTero Lumina solutions are available in your location.
- Compared to the field of view of the iTero Element 5D dental imaging system, when the iTero Lumina intraoral scanner’s scanning distance is 12 mm. Data on file at Align Technology, as of November 15, 2023.
- Compared to the iTero Element 5D dental imaging system with tolerance AVE=±0.1 operating at a working distance from 0-20 mm. Data on file at Align Technology, as of November 15, 2023.
- Based on bench testing conducted using ADA/ANSI 132 standard Model simulating “long distance accuracy (full jaw measurement)” in July 2024. Method: Comparative test to evaluate full arch accuracy (global accuracy), repeatability, and reproducibility of intraoral scanners as described in ADA standard 132 [2015]; Sample definition: 3 operators performed 30 repetitive scans with each tested scanner; Sample size: n=90 (3×30) scans for each scanner tested; Tested scanners: iTero Lumina; Trios 5; CS3800; Medit i700; Allied Star; Results: The accuracy of iTero Lumina is significantly higher than that of all 4 other scanners, with a reduction of total error ranging from 0.11% to 0.46%. Accuracy was defined as the accumulated average error + STD of all measurements specified in the standard. Data on file at Align Technology, as of August 26, 2024.
- Based on bench testing conducted in June 2024 according to ADA/ANSI 132 standard requirements for long-distance full jaw accuracy (average error =0.03% – 0.24% < 0.25%), crown accuracy (average error =0% – 0.9% < 1%) and inlay accuracy specimens (average error =0% – 0.4% < 1%). Data on file at Align Technology, as of August 26, 2024.
- Based on bench testing conducted in January 2025 according to ISO 20896-2:2023 vs. Ground truth: Imetric icam 4D Photogrammetry system; Sample size: n=10; 5 upper arch model (All-on-6) and 5 lower arch model (All-on-4). Thresholds were defined as Horizontal error <50µm; Vertical error <30µm & Angular deviation < 0.4°.
- Based on clinical data collected in January 2024 of n=15 subjects who participated in a clinical study with iTero Lumina intraoral scanner. Data reviewed by Invisalign-trained practitioners (Orthodontists and GPs) in conjunction with Align clinical team. Data on File at Align Technology, as of January 31, 2024. Cannot be used to imply that intraoral photographs may not be needed for practice patient records.
- iTero NIRI technology is available on iTero Lumina Pro imaging system.
- For Invisalign record-taking cases only. Based on a survey in September 2023 of n=22 users who participated in a global limited market release, working with iTero Lumina intraoral scanner for an average period of 6 months, representing both Invisalign-trained general practitioners, orthodontists, and their staff in NA, EU, and APAC, who were presented with a 4-point level of agreement scale from strongly agree to strongly disagree with the following statement: “iTero Lumina intraoral scanner 3D model’s superior 3D model eliminates the need to take intraoral photos” and “iTero Lumina intraoral scanner 3D model’s superior 3D model boosts patient engagement.” *Data on file at Align Technology, as of November 15, 2023.
- Compared to iTero Element 5D imaging system wand. Data on file at Align Technology, as of November 15, 2023.
- Based on assessing intraoral topographical images of hard and soft tissues and NIRI images.Based on bench testing conducted in January 2025 according to ISO 20896-2:2023 vs. Ground truth: Imetric icam 4D Photogrammetry system; Sample size: n=10; 5 upper arch model (All-on-6) and 5 lower arch model (All-on-4). Thresholds were defined as Horizontal error <50µm; Vertical error <30µm & Angular deviation < 0.4°. This claim is only relevant to specific markets, not including the EU at this stage.
About Align Technology, Inc.
Align Technology designs and manufactures the Invisalign System, the most advanced clear aligner system in the world, iTero intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 271.6 thousand doctor customers and are key to accessing Align’s 600 million consumer market opportunity worldwide. Over the past 28 years, Align has helped doctors treat approximately 19.5 million patients with the Invisalign System and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.
For additional information about the Invisalign System or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.
