# K090119: Sicat Implant

- Pathway: 510(k) (Traditional)
- Applicant: Sicat GmbH & Co. KG
- Decided: Feb 5, 2009 after 15 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: 4 generations back to K924630 (1993). 5 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 14 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.
- K061472: Galileos Implant, V 1.0, Sicat GmbH & Co. KG (2006) Summary page 2.

## Most influential descendants
- 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
- K192348: SICAT Implant V2.0 (2019), 0 descendants of its own

## Indications for use
SICAT Implant is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. SICAT 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 treatments. The dental professionals' planning data may be exported from SICAT Implant and used as input data for CAD or Rapid Prototyping Systems.

Source page: https://510kreport.com/device/K090119
Methodology: https://510kreport.com/methodology