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1 Based on data from a multi-site US IDE (Investigational Device Exemption) clinical study (n=29 subjects, ages 7-10 years) of expansion treatment with Invisalign Palatal Expanders. Data on file at Align Technology, as of October 30, 2023
2 Based on data from n=49 patients, ages 7-11 years old for which initial and post-expansion intraoral scans were received for expansion treatment with Invisalign Palatal Expanders and from n=3 patients cone-beam computed tomography systems (CBCT) scans analysis of the frontal and palatal views. Data on file at Align Technology, as of February 5, 2024.
3 Based on 8/23 survey from 10 Invisalign-trained orthodontists who participated in the Invisalign Palatal Expander System Technical Design Assessment in CAN. Data on file 10/30/23.
4. Data on File at Align Technology, as of April 26, 2018
5. Based on the global limited market release (LMR), which included NA, EMEA and APAC regions, 54 Invisalign orthodontists and a total enrollment of 784 patients. 31 of the 54 Invisalign orthodontists in the LMR responded to the question: “How likely are you to recommend Invisalign First treatment for growing children (for phase 1 or early interceptive treatment) 19.35% of surveyed Invisalign orthodontists answered “likely” and 80.65% of surveyed Invisalign orthodontists answered “very likely”. Likelihood scale is 1-4 with 1 being “very unlikely” and 4 being “very likely”.
6. Based on the global survey in December 2020 to March 2021 in NA, EMEA and APAC regions, 224 Invisalign orthodontists responded to the question: “Please indicate your agreement with the following statement: Phase 1 patients treated with Invisalign First aligners experience better quality of life (i.e. including better ability to eat, oral hygiene, impact on their daily activities especially if playing sports/musical instruments) than those patients treated with functional appliances.” Agreement scale is 1-4 with 1 being “strongly disagree” and 4 being “strongly agree”. Data on file at Align Technology, as of April 20, 2021.
7 .Based on the global survey in December 2020 to March 2021 in NA, EMEA and APAC regions, 224 Invisalign orthodontists responded to the question: “Please indicate your agreement with the following statement: “Invisalign First treatment does not interfere with patients’ speech.” Agreement scale is 1-4 with 1 being “strongly disagree” and 4 being “strongly agree. Data on file at Align Technology, as of April 20, 2021.
8 .Based on the global limited market release (LMR), which included NA, EMEA and APAC regions, 54 Invisalign orthodontists and a total enrollment of 784 patients. 31 of the 54 Invisalign orthodontists in the LMR responded to the question: “Please indicate your agreement with the following statement: “Offering Invisalign First treatment will grow my practice.” Agreement scale is 1-4 with 1 being “very unlikely” and 4 being “very likely”.
9. Based on the global limited market release (LMR), which included NA, EMEA and APAC regions, 54 Invisalign orthodontists and a total enrollment of 784 patients. 31 of the 54 Invisalign orthodontists in the LMR responded to the question: “Please indicate your agreement with the following statement: “Invisalign First treatment saves time for the practice by eliminating the need for multiple appliances (e.g. dental expander and partial braces).” Agreement scale is 1-4 with 1 being “strongly disagree” and 4 being “strongly agree”.
10. Compared to the iTero Element™ 5D imaging system. Data on file at Align Technology, as of November 15, 2023.
11. The iTero LuminaTM 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 ElementTM 5D imaging system, when the iTero LuminaTM intraoral scanner’s scanning distance is 12 mm. Data on file at Align Technology, as of November 15, 2023.
12. The iTero LuminaTM intraoral scanner boasts a 25 mm capture distance. Data on file at Align Technology, as of November 15, 2023.
13. 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.
14. Over other iTero™ scanners in their respective clinics. Based on a survey in September 2023 of n=22 users who participated in a global limited market release, working with iTero LuminaTM intraoral scanner for an average period of 6 months, representing both Invisalign® trained general practitioners and orthodontists, and their staff in NA, EMEA and APAC, who were presented with a 4 point level of agreement scale from strongly agree to strongly disagree with the following statement: “The iTero LuminaTM intraoral scanner enables faster and easier scans of children and teenagers.” Data on file at Align Technology, as of November 15, 2023.
15. 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 and 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 photorealistic scans enable orthodontic clinical assessment the same way intraoral photos do.” Data on file at Align Technology, as of November 15, 2023.
16.Compared to the accuracy of the iTero Element™ 5D imaging system. Data on file at Align Technology, as of November 15, 2023.
17. Compared to the iTero Element™ 5D imaging system with tolerance AVE=±0.1 operating at a working distance from 1-20 mm. Data on file at Align Technology, as of November 15, 2023.
18 Compared to iTero Element™ 5D imaging system wand, excluding the wand cable. Data on file at Align Technology, as of November 15, 2023.
