# K112679: Simplant Navigator Personalized Dental Care System

- Pathway: 510(k) (Traditional)
- Applicant: Materialise Dental NV
- Decided: Feb 22, 2012 after 161 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110300: Simplant 2011, Materialise Dental NV (2011) Summary page 3.
- K050393: The Guided Surgery Concept, Nobel Biocare AB (2005) Summary page 2.

## Indications for use
SimPlant Navigator Personalized Dental Care 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 intended as pre-planning software for dental implant placement and surgical treatment. SurgiGuide®9 guides and the BIOMET 3i Navigator Surgical Kit, which are used intra-operatively to prepare the osteotdmy for placement of BLOMET 3i implants pre-operatively determined in the software.

Source page: https://510kreport.com/device/K112679
Methodology: https://510kreport.com/methodology