iTero Element® Plus Series.

1 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. The largest amount of data refers to the numbers of proximal surfaces included in near infra-red imaging trials. Accuracy means the % agreement between the diagnoses from the BWX and NIRI, calculated as [Total agreements] / [Total surfaces] % = [56 (true positive) + 3338 (true negative)] / 3502 = 96.9%. Data on file at Align Technology, as of February 10, 2021.

2 Based on a subset of 59 cases where iTero Element 5D imaging system was compared against the clinical evaluation of posterior proximal carious lesions above the gingiva as observed during caries debridement, reported as part of a multisite clinical study conducted in real world settings comparing iTero NIRI technology (Near Infra-red Imaging) of the iTero Element 5D imaging system to bite-wing x-rays (BWX) (n= 3,502 posterior proximal tooth surfaces out of 5,796 proximal surfaces in 102 patients) as a tool in aiding in detection and diagnosis. Data on file at Align Technology, as of September 2, 2021

3 Accuracy defined as a combination of trueness and precision tested on different substrates, under different lighting conditions, for crown preparation and full-arch scanning. Based on the results of 10 peer-reviewed papers 2018-2020. Data on file at Align Technology, as of April 6, 2020.
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