# K203765: ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray

- Pathway: 510(k) (Traditional)
- Applicant: Zirkonzahn Srl
- Decided: Jul 20, 2021 after 209 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: 10 generations back to K954678 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173041: 3DIEMME RealGUIDE, 3Diemme, Ltd. (2018) Summary page 4.

## Indications for use
ZIRKONZAHN .Implant-Planner is an implant planning and surgery planning software. The software imports and reads DICOM files from CT/CBCT scanners. The patient data is then transformed into 3D volume and different multi-planar 2D images for diagnosis and further implant and surgery guide planning with precise step by step instructions. The software is a stand-alone product that is not connected to any other medical device. Neither automatic diagnosis nor automatic disease detection is performed. The software is intended for use by dental professionals only and requires appropriate training for its use and knowledge in the practice of implantology.

Source page: https://510kreport.com/device/K203765
Methodology: https://510kreport.com/methodology