# K231898: DTX Studio Clinic (4.0)

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Dec 8, 2023 after 163 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: 11 generations back to K954678 (1996). 41 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221921: DTX Studio Clinic 3.0, Nobel Biocare AB (2023) Summary page 4.
- K213562: DTX Studio Clinic 3.0, Nobel Biocare AB (2022) Summary page 4.
- K163122: NobelClinician, DTX Studio implant, Nobel Biocare AB (2017) Summary page 4.

## Most influential descendants
- K252086: DTX Studio Assist (2025), 0 descendants 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. It can be used to support guided implant surgery whereby the results can be exported. DTX Studio Clinic is a computer assisted detection (CADe) device that analyses intraoral radiographs to identify and localize dental findings, which include caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at the margin of an existing restoration and bone loss. The DTX Studio Clinic CADe functionality is indicated for use by dentists for the concurrent review of bitewing and periapical radiographs of permanent teeth in patients 15 years of age or older.

Source page: https://510kreport.com/device/K231898
Methodology: https://510kreport.com/methodology