iTero™ Intraoral scanners

* Based on a multisite clinical study conducted in real-world settings using iTero NIRI technology (Near Infra-red imaging) (n= 5,796 proximal tooth surfaces with 3,502 posterior proximal tooth surfaces in 102 patients ) as a tool in aiding in detection and diagnosis of interproximal caries above the gingiva. Data on file at Align Technology, as of February 10, 2021.

**Data on file at Align Technology, as of December 4, 2018.

iTero Element 5D is currently available in: U.S., Canada, European Union, and any other country that accepts CE marking, including Australia, New Zealand, and Hong Kong. 1. iTero Element 5D - Laptop configuration is recommended to be used with certified laptops, that are to be purchased separately. For an updated list of recommended laptop models, please refer to iTero.com or contact your local iTero sales representative.

1. 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 (3x30) 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 competitors; 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.

2. 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.

3. Compared to the iTero Element™ 5D 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.

4. The iTero Lumina intraoral scanner offers 3x larger field of view designed for more surface area capture enabling faster scanning.*Compared to the field of view of the iTero Element 5D 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.

5. 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. Can not be used to imply that intraoral photographs may not be needed for practice patient records.

6. Compared to iTero Element 5D imaging system wand. Data on file at Aligh Technology, as of November 15, 2023.

7. The laptop is supported by Dell through the ProSupport Extended Warranty service provided by Dell. When troubleshooting, an iTero Support agent can connect practice directly with Dell to help facilitate support.

8. Align’s Customer Support team will be the focal point of contact for all support issues, including hardware related to iTero and laptop support through Dell.

9. Following initial one or three-year service plan, additional charges will apply for remote support connection and repairs for customers not on a service plan. Additional charges may apply for software upgrades and cloud storage for customers not on a service plan. 

Unless otherwise indicated, as referenced herein, all trademarks and intellectual property rights are the property of ZimVie Inc. or an affiliate; and all products are manufactured by one or more of the dental subsidiaries of ZimVie Inc. (Biomet 3i, LLC, Zimmer Dental, Inc., etc.) and marketed and distributed by ZimVie Dental and its authorized marketing partners. Align, iTero, iTero Element and iTero Lumina are trademarks of Align Technology, Inc For additional product information, please refer to the individual product labeling or instructions for use. Product clearance and availability may be limited to certain countries/regions. This material is intended for clinicians only and does not comprise medical advice or recommendations. Distribution to any other recipient is prohibited. This material may not be copied or reprinted without the express written consent of ZimVie, Inc. ZV2830 US-CAN REV A 05/25 ©2025. ZimVie, Inc. All rights reserved.