# K131101: Itero Software

- Pathway: 510(k) (Traditional)
- Applicant: Cadent, Ltd. an Align Technology Company
- Decided: Aug 26, 2013 after 129 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K894844 (1990). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062493: Lava Software, 3M Espe AG Dental Products (2006) Summary page 2.
- K093113: Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment, Institut Straumann AG (2009) Summary page 2.

## Indications for use
iTero software is used with the iTero scanner in capturing 3D digital impressions of teeth, oral soft tissue and structures, and bite relationship. iTero software controls the processing of the data, facilitating the integration of data, and exporting of the data for CAD/CAM fabrication of dental restorations, orthodontic devices, abutments, and accessories. In addition to scan data, various patient and case information can be imported/exported or used for simulation purposes. Other functions are available for verification and service of the system and to serve as an order management tool.

Source page: https://510kreport.com/device/K131101
Methodology: https://510kreport.com/methodology