# K180262: SICAT Endo

- Pathway: 510(k) (Traditional)
- Applicant: Sicat GmbH & Co. KG
- Decided: Mar 12, 2018 after 41 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: 6 generations back to K924630 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103723: Sicat Implant V1.2, Sicat GmbH & Co. KG (2011) Summary page 4.
- K171115: 3D Endo Software, Dentsply Sirona (2017) Summary page 4.

## Indications for use
• Aiding diagnosis in the oral-maxillofacial region • Aiding comparisons of different treatment options • Aiding endodontic treatment planning • Aiding treatment planning for endodontic surgical guides

Source page: https://510kreport.com/device/K180262
Methodology: https://510kreport.com/methodology