# K221921: DTX Studio Clinic 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Mar 28, 2023 after 270 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: 2 generations back to P980025 (1998). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213795: Videa Caries Assist, Videahealth, Inc. (2022) Summary page 4.
- K210365: Second Opinion, Pearl, Inc. (2022) Summary page 5.

## Most influential descendants
- K231678: Overjet Periapical Radiolucency Assist (2023), 2 descendants of its own
- K231898: DTX Studio Clinic (4.0) (2023), 1 descendant of its own
- K252934: Diagnocat (2026), 0 descendants of its own
- K252086: DTX Studio Assist (2025), 0 descendants of its own
- K242600: Second Opinion Periapical Radiolucency Contours (2025), 0 descendants of its own

## Indications for use
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 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/K221921
Methodology: https://510kreport.com/methodology