# K163122: NobelClinician, DTX Studio implant

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Jan 31, 2017 after 84 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). 17 ancestors in all.
2 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)
- K123976: Nobelclinician, Nobel Biocare AB (2013) Summary page 4.

## Most influential descendants
- 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
NobelClinician® (DTX Studio Implant) is a software interface for the transfer and visualization of 2D and 3D image information from equipment such as a CT scanner for the purposes of supporting the diagnostic process, treatment planning and follow-up in the dental and cranio-maxillofacial regions, NobelClinician® (DTX Studio Implant) can be used to support guided implant surgery and to provide design input for and review of dental restorative solutions, The results can be exported to be manufactured.

Source page: https://510kreport.com/device/K163122
Methodology: https://510kreport.com/methodology