# K110300: Simplant 2011

- Pathway: 510(k) (Special)
- Applicant: Materialise Dental NV
- Decided: Jul 1, 2011 after 149 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.
20 later devices descend from it; 9 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)
- K053592: Simplant DR. James, Materialise NV (2006) 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
- K113739: Simplant Immediate Smile Dental Care System (2012), 3 descendants of its own
- K173041: 3DIEMME RealGUIDE (2018), 2 descendants of its own
- K170849: SIMPLANT Guide (2017), 2 descendants of its own

## Indications for use
SimPlant 2011 is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also intended as pre-planning software for dental implant placement and surgical treatment.

Source page: https://510kreport.com/device/K110300
Methodology: https://510kreport.com/methodology