# K252086: DTX Studio Assist

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare C/O Medicim NV
- Decided: Nov 17, 2025 after 138 days
- Product code: MYN (Analyzer, Medical Image)
- Device class: 2
- Regulation: 21 CFR 892.2070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K954678 (1996). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231898: DTX Studio Clinic (4.0), Nobel Biocare AB (2023) Summary page 5.
- K242437: Smile Dx®, Cube Click, Inc. (2025) Summary page 5.

## Indications for use
DTX Studio Assist is a Software Development Kit (SDK) designed to integrate with medical device software that displays two-dimensional dental radiographs. It contains a selection of algorithms that processes input data (two-dimensional radiographs) from the hosting application and returns a corresponding output to it. DTX Studio Assist is intended to support the measurement of alveolar bone levels associated with each tooth. It is also intended to aid in the detection and segmentation of non-pathological structures (i.e., restorations and dental anatomy). DTX Studio Assist contains a computer-assisted detection (CADe) function that analyzes bitewing and periapical radiographs of permanent teeth in patients aged 15 and older to identify and localize dental findings, including caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at the margin of an existing restoration, and bone loss. DTX Studio Assist is not intended as a replacement for a complete dentist's review nor their clinical judgment which takes into account other relevant information from the image, patient history, and actual in vivo clinical assessment

Source page: https://510kreport.com/device/K252086
Methodology: https://510kreport.com/methodology