# K193390: CS Model+

- Pathway: 510(k) (Traditional)
- Applicant: Trophy
- Decided: Apr 2, 2020 after 118 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: 3 generations back to K082207 (2009). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171634: Ortho System, 3Shape A/S (2018) Summary page 4.

## Indications for use
CS Model+ is intended for use as a front-end software tool for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design options, including dental casts and orthodontic appliances. These applications are based on 3D models of the patient’s dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of CS Model+ requires the user to have the necessary training and domain knowledge in the practice of orthodontics.

Source page: https://510kreport.com/device/K193390
Methodology: https://510kreport.com/methodology