# K163677: Ortho System

- Pathway: 510(k) (Traditional)
- Applicant: 3Shape A/S
- Decided: Apr 20, 2017 after 114 days
- Product code: PNN (Orthodontic Software)
- 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: 2 generations back to K082207 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152086: 3Shape Ortho System, 3Shape A/S (2016) Summary page 4.

## Indications for use
3Shape Ortho System™ for dental retainers is intended for use as a medical front-end device providing tools for management of orthodontic models. systematic inspection. detailed analysis, treatment simulation and virtual appliance design based on 3D models of the patient’s dentition before the start of an orthodontic treatment. The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Source page: https://510kreport.com/device/K163677
Methodology: https://510kreport.com/methodology