# K061472: Galileos Implant, V 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Sicat GmbH & Co. KG
- Decided: Jun 9, 2006 after 10 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: 3 generations back to K924630 (1993). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 15 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 1.

## Most influential descendants
- K090119: Sicat Implant (2009), 8 descendants of its own
- K103723: Sicat Implant V1.2 (2011), 5 descendants of its own
- K133320: Sicat Function (2014), 2 descendants of its own
- K113404: Dental 3D Planning Software (2011), 1 descendant of its own
- K183676: DentiqAir (2019), 0 descendants of its own

## 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. GALLEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALULEOS medical cone beam scanner. The dental professionals' input information may be exported from GALILEOS Implant and used as input data for CAD or Rapid Prototyping Systems.

Source page: https://510kreport.com/device/K061472
Methodology: https://510kreport.com/methodology