# K213916: ArchForm Orthodontic Software System

- Pathway: 510(k) (Traditional)
- Applicant: Archform, Inc.
- Decided: Dec 16, 2021 after 1 day
- 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: 4 generations back to K082207 (2009). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181112: Orchestrate 3D, Orchestrate 3D (2018) Summary page 4.

## Most influential descendants
- K253565: SureSmile Software (2026), 0 descendants of its own

## Indications for use
The ArchForm Orthodontic Software System is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. 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 the ArchForm Orthodontic Software 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/K213916
Methodology: https://510kreport.com/methodology