# K193003: NemoCast

- Pathway: 510(k) (Traditional)
- Applicant: Software Nemotec S.L.
- Decided: Jun 5, 2020 after 221 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
NemoCast is intended for supporting the diagnostic and treatment plan processes for orthodontic procedures related to minor anterior tooth movements; it provides tools for management of orthodontic models, systemic inspection, detailed analysis, treatment simulation and virtual appliance design options (export of models) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied to evaluate if the outcome is consistent with the planned/desired treatment objectives. NemoCast 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/K193003
Methodology: https://510kreport.com/methodology