# K152078: Implant Studio 2015

- Pathway: 510(k) (Traditional)
- Applicant: 3Shape Medical A/S
- Decided: Dec 4, 2015 after 130 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: 8 generations back to K954678 (1996). 14 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 22 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.
- K130724: Codiagnostix Implant Planning Software, Straumann USA (2013) Summary page 4.
- K141570: Implant Studio, 3Shape Medical A/S (2014) Summary page 4.

## Most influential descendants
- K173041: 3DIEMME RealGUIDE (2018), 2 descendants of its own
- K183458: exoplan 2.3 (2019), 1 descendant of its own
- K180629: DentiqGuide (2018), 1 descendant of its own
- K253902: RealGUIDE (2026), 0 descendants of its own
- K213302: exoplan (2022), 0 descendants of its own

## Indications for use
Implant Studio™ is indicated for use as a medical front-end software that can be used by medically trained professionals for the purpose of visualizing gray value images. It is intended for use as a pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.

Source page: https://510kreport.com/device/K152078
Methodology: https://510kreport.com/methodology