# K191911: 3Shape Splint Design

- Pathway: 510(k) (Traditional)
- Applicant: 3Shape A/S
- Decided: Nov 27, 2019 after 133 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: 1 generation back to K161884 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161884: Ortho System, 3Shape A/S (2017) Summary page 4.

## Indications for use
3Shape Splint Design for splints and mouthguards/nightguards is intended for use as a medical front-end device providing tools for 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 Splint Design software 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/K191911
Methodology: https://510kreport.com/methodology