# K123416: Insignia with Itero

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corp.
- Decided: Mar 13, 2013 after 127 days
- Product code: DYW (Bracket, Plastic, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K944964 (1995). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121524: Insignia, Ormco Corp. (2012) Summary page 2.
- K102209: Encode Patient Specific Abutment, Biomet 3i, Inc. (2010) Summary page 1.

## Indications for use
Insignia with iTero is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient. The Insignia Orthodontic System is compatible with the iTero scanner.

Source page: https://510kreport.com/device/K123416
Methodology: https://510kreport.com/methodology