# K202256: 3Shape Implant Studio

- Pathway: 510(k) (Traditional)
- Applicant: 3Shape Medical A/S
- Decided: Sep 9, 2020 after 30 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.
1 later device descends from it; 1 cites it directly.
0 of 13 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.

## Most influential descendants
- K230012: Atomica Planner (2023), 0 descendants of its own

## Indications for use
3Shape Implant Studio is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement. Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.

Source page: https://510kreport.com/device/K202256
Methodology: https://510kreport.com/methodology