# K171115: 3D Endo Software

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Jul 17, 2017 after 94 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K924630 (1993). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110300: Simplant 2011, Materialise Dental NV (2011) Summary page 4.

## Most influential descendants
- K180262: SICAT Endo (2018), 0 descendants of its own

## Indications for use
3D Endo™ Software is intended to aid in the visualization, diagnosis and planning of endodontic treatment and re-treatment cases utilizing DICOM images.

Source page: https://510kreport.com/device/K171115
Methodology: https://510kreport.com/methodology