# K192244: Arcad SmileStudio and Aligner System

- Pathway: 510(k) (Traditional)
- Applicant: Arcadlab
- Decided: May 11, 2020 after 266 days
- Product code: NXC (Aligner, Sequential)
- 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: 5 generations back to K780619 (1978). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180941: Ortho System, 3Shape A/S (2018) Summary page 4.
- K113618: Clearcorrect System, Clearcorrect, Inc. (2012) Summary page 4.

## Most influential descendants
- K221845: Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G (2023), 0 descendants of its own

## Indications for use
The Arcad SmileStudio 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 design of a series of dental casts, which may be used for sequential aligner trays or retainers, 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 Arcad Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Arcad Aligner System positions teeth by way of continuous gentle force. The use of the Arcad Aligner System and SmileStudio requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

Source page: https://510kreport.com/device/K192244
Methodology: https://510kreport.com/methodology