# K151152: ImplantMax Software

- Pathway: 510(k) (Traditional)
- Applicant: Saturn Imaging, Inc.
- Decided: Jan 12, 2016 after 257 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: 7 generations back to K954678 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130724: Codiagnostix Implant Planning Software, Straumann USA (2013) Summary page 4.

## Indications for use
ImplantMax Software is a stand-alone Windows-based software application to support the diagnosis and treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners and transfers the dataset into 3D dataset for pre-operative planning and simulation of dental placement. The planned implant position can be exported and displayed as the position data of each joint of the articulated arm of ImplantMax Workstation. The user can manually set the position of ImplantMax Workstation arm to match the setting values displayed by ImplantMax Software. ImplantMax Workstation is set to the position to fabricate the surgical template. Please note that ImplantMax Workstation is not part of this 510(k) premarket notification. The patient population is the general public.

Source page: https://510kreport.com/device/K151152
Methodology: https://510kreport.com/methodology