# K081402: Simplant Ortho ; Vistadent 3D

- Pathway: 510(k) (Traditional)
- Applicant: Materialise Dental NV
- Decided: Jul 18, 2008 after 60 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.
7 later devices descend from it; 3 cite it directly.
0 of 13 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
- K103723: Sicat Implant V1.2 (2011), 5 descendants of its own
- K133320: Sicat Function (2014), 2 descendants of its own
- K183676: DentiqAir (2019), 0 descendants of its own
- K192348: SICAT Implant V2.0 (2019), 0 descendants of its own
- K180262: SICAT Endo (2018), 0 descendants of its own

## Indications for use
Materialise Dental's SimPlant Ortho; Vistadent 3D software is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It 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 software system for simulating/evaluating orthodontic treatment i.e. dental bite options.

Source page: https://510kreport.com/device/K081402
Methodology: https://510kreport.com/methodology