# K130724: Codiagnostix Implant Planning Software

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Jun 28, 2013 after 102 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: 6 generations back to K954678 (1996). 10 ancestors in all.
15 later devices descend from it; 7 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071636: Codiagnostix (R) 5.72, Ivs Solutions AG (2007) Summary page 1.

## Most influential descendants
- K141570: Implant Studio (2014), 8 descendants of its own
- K152078: Implant Studio 2015 (2015), 7 descendants of its own
- K173041: 3DIEMME RealGUIDE (2018), 2 descendants of its own
- K202256: 3Shape Implant Studio (2020), 1 descendant of its own
- K183458: exoplan 2.3 (2019), 1 descendant of its own

## Indications for use
coDiagnostiX is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT or DVT scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement. For automated manufacturing of drill guides in the dental laboratory environment. the coDiagnostiX software allows for export of data to 3D manufacturing systems. Alternatively, coDiagnostiX can provide printouts of template plans for the creation of surgical templates using a manually operated gonyX table.

Source page: https://510kreport.com/device/K130724
Methodology: https://510kreport.com/methodology