# K053592: Simplant DR. James

- Pathway: 510(k) (Special)
- Applicant: Materialise NV
- Decided: Feb 8, 2006 after 47 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: 3 generations back to K924630 (1993). 4 ancestors in all.
68 later devices descend from it; 7 cite it directly.
0 of 73 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.

## Most influential descendants
- K070803: Invivodental (2007), 38 descendants of its own
- K123519: Invivo  Dental (2013), 24 descendants of its own
- K110300: Simplant 2011 (2011), 20 descendants of its own
- K140713: Planmeca Romexis (2014), 14 descendants of its own
- K162799: Cliniview (2017), 13 descendants of its own

## Indications for use
The Materialise SimPlant System 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 used as a pre-operative software for simulating /evaluating dental implant placement and surgical treatment options.

Source page: https://510kreport.com/device/K053592
Methodology: https://510kreport.com/methodology