# K093090: Galileos Implant, Version 1.7

- Pathway: 510(k) (Traditional)
- Applicant: Sicat GmbH & Co. KG
- Decided: Dec 17, 2009 after 77 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033849: Simplant System, Materialise NV (2004) Summary page 2.
- K053592: Simplant DR. James, Materialise NV (2006) Summary page 2.
- K081402: Simplant Ortho ; Vistadent 3D, Materialise Dental NV (2008) Summary page 2.
- K061472: Galileos Implant, V 1.0, Sicat GmbH & Co. KG (2006) Summary page 2.

## Indications for use
GALILEOS Implant is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical implant treatments. GALILEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALILEOS medical cone beam scanner. The dental professionals' input information may be exported from GALILEOS Implant and used as input data for CAD (Computer-Aided Design) or Rapid Prototyping Systems.

Source page: https://510kreport.com/device/K093090
Methodology: https://510kreport.com/methodology