# K212770: Vision

- Pathway: 510(k) (Traditional)
- Applicant: Softsmile, Inc.
- Decided: Dec 21, 2021 after 112 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.
2 later devices descend from it; 2 cite 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)
- K171295: ULab Systems Treatment Planning Software, Ulab Systems, Inc. (2018) Summary page 5.

## Most influential descendants
- K252507: SmileInspector (2026), 0 descendants of its own
- K233616: Clevaligner Software  (V1.0.0) (2024), 0 descendants of its own

## Indications for use
The SoftSmile Vision 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 use of SoftSmile Vision 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/K212770
Methodology: https://510kreport.com/methodology