# K052840: Igi-System

- Pathway: 510(k) (Traditional)
- Applicant: Denx Advanced Dental Systems
- Decided: Dec 16, 2005 after 70 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983831 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023424: Igi-System, Denx Advanced Dental Systems (2003) Summary page 1.

## Indications for use
The IGI-SystemTM, inage-Guided Implantation System, is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides accurate navigational guidance of surgical instruments, with regard to the pre-operative planning in dental implantation procedure. The device is intended for use for partially edentulous and edentulous patients who require dental implants as part of their treatment plan.

Source page: https://510kreport.com/device/K052840
Methodology: https://510kreport.com/methodology