# K153091: Implant 3D

- Pathway: 510(k) (Traditional)
- Applicant: Media Lab S.R.L.
- Decided: Feb 25, 2016 after 122 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.
No later device cites it as a predicate yet.
0 of 7 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 4.

## Indications for use
Implant 3D 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 CAT scanner. It is also intended as pre-planning software for dental implant placement.

Source page: https://510kreport.com/device/K153091
Methodology: https://510kreport.com/methodology