- What it does: DS Core is Dentsply Sirona's cloud platform. It holds FDA clearances for DS Core Detect (radiograph detection), DS Core Diagnosis, and DS Core CBCT Anatomy (AI segmentation of CBCT and intraoral scans), making it the largest equipment maker with cleared dental AI.
- Regulatory: 4 FDA 510(k) clearances (K262127, K260785, K253009, K250755)
- Pricing: Not published (Bundled with DS Core subscriptions; quote via Dentsply Sirona)
- Best fit: group, dso, specialist
FDA clearances
What the FDA cleared, in the words of the decision. Anything not listed here is outside the clearance, even if the product does it.
| 510(k) | Device | Decision | Cleared for |
|---|---|---|---|
| K262127 | DS Core CBCT Anatomy | Aug 21, 2026 | Segments anatomy on CBCT scans and intraoral (digital impression) scans for diagnostic review and treatment planning (updated clearance). |
| K260785 | DS Core CBCT Anatomy | Apr 23, 2026 | Cloud AI service that segments anatomy on CBCT scans and intraoral (digital impression) scans for diagnostic review and treatment planning. |
| K253009 | DS Core Detect | Jan 7, 2026 | DS Core Detect: computer-aided detection of findings on dental radiographs. See the FDA filing for the exact findings and image types. |
| K250755 | DS Core Diagnosis | Aug 12, 2025 | DS Core Diagnosis: software to support review and diagnosis of dental images. See the FDA filing for the full indications. |
Capabilities
Imaging modalities: bitewing, periapical, panoramic, CBCT, intraoral scan.
- Four FDA clearances (2025–2026) across 2D, CBCT and intraoral scans
- Native to Dentsply Sirona imaging hardware (Primescan, CBCT units)
- Most useful if your imaging hardware is already Dentsply Sirona
What we have not verified
We have not evaluated DS Core in a practice. Several FDA summaries were image-only; see each filing for exact indications.
Common questions
Is Dentsply Sirona DS Core FDA cleared?
Yes. Dentsply Sirona DS Core holds 4 FDA 510(k) clearances: K262127 (Aug 21, 2026) for segments anatomy on CBCT scans and intraoral (digital impression) scans for diagnostic review and treatment planning (updated clearance).; K260785 (Apr 23, 2026) for cloud AI service that segments anatomy on CBCT scans and intraoral (digital impression) scans for diagnostic review and treatment planning.; K253009 (Jan 7, 2026) for dS Core Detect: computer-aided detection of findings on dental radiographs. See the FDA filing for the exact findings and image types.; K250755 (Aug 12, 2025) for dS Core Diagnosis: software to support review and diagnosis of dental images. See the FDA filing for the full indications.. Features outside those indications are not covered by the clearance.
How much does Dentsply Sirona DS Core cost?
Dentsply Sirona DS Core does not publish pricing; it is quoted by sales (Bundled with DS Core subscriptions; quote via Dentsply Sirona).