# K210241: ImplaStation

- Pathway: 510(k) (Traditional)
- Applicant: Prodigident, Inc.
- Decided: Dec 3, 2021 after 308 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
ImplaStation is stand-alone software designed for trained qualified dental practitioners, including dentists and dental technicians. The software can be used to visualize a patient’s medical image dataset output in DICOM format from third-party CT/CBCT scanners. ImplaStation is intended for use as a pre-operative tool for the dental implant(s) positioning based on the CT/CBCT image dataset aligned to optical 3D surface scan(s) and for the surgical guide planning result file creation. The surgical guide can be manufactured using a planning result file when used as input to 3D manufacturing systems. 3D manufacturing is out of ImplaStation software control, depends on many external factors and lie within the sole responsibility of the user.

Source page: https://510kreport.com/device/K210241
Methodology: https://510kreport.com/methodology