Dentsply Sirona’s DS Core CBCT Anatomy received FDA 510(k) clearance K262127 on August 21, 2026, four months after its first clearance. The company’s 510(k) summary describes cloud-based AI software that identifies anatomy on CBCT scans, segments teeth, jaws and the inferior alveolar nerve canal, and registers CBCT data with intraoral scans.
What happened
The FDA’s 510(k) database lists DS Core CBCT Anatomy from Dentsply Sirona, of York, Pennsylvania, as cleared on August 21, 2026. The FDA received the submission on June 24, 2026. It’s a Class II device under product code QIH, a medical image management and processing system reviewed by the FDA’s radiology panel.
The August clearance builds on an earlier one. The predicate device listed in its 510(k) summary is DS Core CBCT Anatomy itself, cleared on April 23, 2026, as K260785. For that April clearance, Dentsply Sirona named Second Opinion 3D (K243989), cleared for Pearl, Inc. in 2025, and Relu Creator (K233925) as predicates.
According to the Indications for Use in the April clearance, the software is intended for dental professionals reviewing CBCT scans and intraoral scans during diagnostic review and treatment planning. It identifies anatomical structures, proposes a panoramic curve, segments teeth, jaws and the nerve canal, and registers the two kinds of scans to each other. It’s for patients aged 12 and older with permanent dentition. The device description in the August 510(k) summary adds an automatic comparison of two intraoral scans.
Why it matters for dental practices
For a practice that takes CBCT scans, this is one more FDA-cleared option for automatic segmentation and nerve canal tracing, and one that also works with intraoral scans. Dentsply Sirona’s filings describe it as a backend service reached through an API, so it reaches dentists through other software, not as an app of its own. The August summary says it is meant to give supplementary visualizations while preserving clinician oversight and decision-making.
What we don’t know yet
We found no company announcement for this clearance as of October 19, 2026. The FDA documents don’t say what it costs, how it is sold, or which imaging and practice software it works with. Ask your Dentsply Sirona representative before you plan around it.
Sources
- FDA 510(k) database: K262127, DS Core CBCT Anatomy, accessed October 19, 2026
- FDA decision letter and 510(k) summary, K262127, accessed October 19, 2026
- FDA 510(k) database: K260785, DS Core CBCT Anatomy, accessed October 19, 2026
- FDA decision letter, Indications for Use and 510(k) summary, K260785, accessed October 19, 2026
- FDA 510(k) database: K243989, Second Opinion 3D, accessed October 19, 2026
