# K123976: Nobelclinician

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Mar 26, 2013 after 90 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). 16 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112251: Swissmeda Dental Planning System, Swissmeda AG (2012) Summary page 1.
- K050393: The Guided Surgery Concept, Nobel Biocare AB (2005) Summary page 1.
- K052424: Maxilim, Medicim NV (2006) Summary page 1.

## Most influential descendants
- 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
The NobelClinician software is a software interface for the transfer and visualization of imaging information from equipment such as a CT scanner or a magnetic resonance scanner for the purposes of diagnosis and treatment planning in the dental and cranio-maxillofacial regions. The NobelClinician software can be used to design a surgical template for the purposes of aiding placement of dental implants.

Source page: https://510kreport.com/device/K123976
Methodology: https://510kreport.com/methodology
