# K253565: SureSmile Software

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona, Inc.
- Decided: Mar 4, 2026 after 107 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: 5 generations back to K082207 (2009). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213916: ArchForm Orthodontic Software System, Archform, Inc. (2021) Summary page 5.

## Indications for use
The SureSmile Software is indicated for use as a front-end device for management of orthodontic models, systematic inspection, detailed analysis, treatment planning and simulation and the design of custom appliance systems, which may include sequential aligners, retainers, IDB trays, brackets, or wires, and dental casts. These applications are based on 3D models of the patient's dentition before the start of the 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 SureSmile 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/K253565
Methodology: https://510kreport.com/methodology