# K192348: SICAT Implant V2.0

- Pathway: 510(k) (Traditional)
- Applicant: Sicat GmbH & Co. KG
- Decided: Dec 4, 2019 after 97 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924630 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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.

## Recalls of this device
- Jul 15, 2020 · Class II · Z-2951-2020: A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.

## 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 CBCT scanners. SICAT Implant is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data can be exported from SICAT Implant. This planning data includes in particular the positions, orientations and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture surgical guides for dental implants.

Source page: https://510kreport.com/device/K192348
Methodology: https://510kreport.com/methodology