# K113404: Dental 3D Planning Software

- Pathway: 510(k) (Traditional)
- Applicant: Symbyo Dental, LLC
- Decided: Dec 6, 2011 after 18 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: 5 generations back to K924630 (1993). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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.
- K090119: Sicat Implant, Sicat GmbH & Co. KG (2009) Summary page 1.

## Most influential descendants
- K173083: Implanter Dental Planning Software (2018), 0 descendants of its own

## Indications for use
IFS is prescription use software used by dentists and dental lab technicians for the visualization and image segmentation of DICOM data from medical scanners such as CT. The software aids the user in the creation of 3D models of oral maxillofacial region and in planning dental surgical treatments and placement of dental implants.

Source page: https://510kreport.com/device/K113404
Methodology: https://510kreport.com/methodology