# K262127: DS Core CBCT Anatomy

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Aug 21, 2026 after 58 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 14 generations back to K954678 (1996). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K260785: DS Core CBCT Anatomy, Dentsply Sirona (2026) Summary page 5.

## Indications for use
“DS Core CBCT Anatomy” is a cloud-based Al/ML enabled software as a medical device. The device is available as a back end service via an API (Application Programming Interface). The device is intended to be used by dental professionals when reviewing Digital Impression (DI) scans and CBCT (DX) scans during standard of care diagnostic review and treatment planning. DS Core CBCT Anatomy analyses CBCT scans and Digital Impression (DI) scans to identify anatomical structures, propose a panoramic curve, segmentation of teeth, jaws, and the inferior alveolar nerve canal (IAN), as well as to perform image registration to support the review of CBCT dental images and DI scans. This device is intended to be used with patients aged 12 and older with permanent dentition.

Source page: https://510kreport.com/device/K262127
Methodology: https://510kreport.com/methodology