# K112251: Swissmeda Dental Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Swissmeda AG
- Decided: Jan 25, 2012 after 173 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: 6 generations back to K954678 (1996). 10 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071636: Codiagnostix (R) 5.72, Ivs Solutions AG (2007) Summary page 1.

## Most influential descendants
- K123976: Nobelclinician (2013), 3 descendants of its own
- K163122: NobelClinician, DTX Studio implant (2017), 2 descendants of its own
- K231898: DTX Studio Clinic (4.0) (2023), 1 descendant of its own
- K252086: DTX Studio Assist (2025), 0 descendants of its own

## Indications for use
Swissmeda Dental Planning System is intended for use by qualified dental professionals for WindowsO based diagnostics and implant planning. The software is an interface for imaging data that originates from medical scanners such as ar or DVT scanners and it is also a pre-operative software for simulation and evaluation of dental implant placement in the patient's mandible/maxilla and for surgical treatment options. Swissmeda Implant Planning System is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices. The planning data may be exported from Swissmeda Dental Planning System and used as input data for a special drilling device from company Georg Schick for manufacturing drilling templates in a laboratory environment. The drilling template isthen used in direct contact with the patient to realize the implant planning.

Source page: https://510kreport.com/device/K112251
Methodology: https://510kreport.com/methodology