# K203156: DTX Studio Clinic

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Nov 20, 2020 after 29 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: 9 generations back to K954678 (1996). 26 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162799: Cliniview, Palodex Group OY (2017) Summary page 4.

## Most influential descendants
- K213562: DTX Studio Clinic 3.0 (2022), 9 descendants of its own
- K233925: Relu Creator (2024), 6 descendants of its own
- K243989: Second Opinion® 3D (2025), 3 descendants of its own
- K260785: DS Core CBCT Anatomy (2026), 1 descendant of its own
- K231898: DTX Studio Clinic (4.0) (2023), 1 descendant of its own

## Indications for use
DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

Source page: https://510kreport.com/device/K203156
Methodology: https://510kreport.com/methodology