Diagnocat vs Dentsply Sirona DS Core
AI-powered CBCT and panoramic radiograph analysis with automated segmentation and reporting.
FDA 510(k) cleared ×2vs
AI built into Dentsply Sirona's cloud platform: CBCT periapical detection, diagnosis support and CBCT/scan anatomy
FDA 510(k) cleared ×4For flagging periapical radiolucency on CBCT, the two clearances are close to identical. Diagnocat (K252934) and DS Core Detect (K253009) both cover permanent teeth in patients 22 and older, as a read alongside the dentist, on scans already taken for another reason. So the choice is about the platform. Diagnocat suits a practice that wants to buy CBCT reads on its own, because it lists self-serve prices (plans with CBCT reports start at €590 for six months). DS Core suits a practice already on Dentsply Sirona imaging, and it adds clearances for CBCT and intraoral-scan anatomy (K260785, K262127). Dentsply Sirona quotes its pricing.
Diagnocat or Dentsply Sirona DS Core: which should you choose?
- You want to sign up online at a listed price rather than wait for a quote
- You want CBCT segmentation and STL export in the same tool (Segmentron Viewer, K251072; STL output is cleared for educational use only)
- You don't use other Dentsply Sirona software
- You already use DS Core or Dentsply Sirona imaging
- You also want CBCT and intraoral-scan anatomy segmentation under FDA clearance (K260785, K262127)
- You'd rather have the AI inside your imaging platform than buy a set number of reports
Diagnocat vs Dentsply Sirona DS Core: FDA clearances, price and integrations side by side
| Diagnocat | Dentsply Sirona DS Core | |
|---|---|---|
| Vendor | DGNCT LLC (Diagnocat) · Miami, FL | Dentsply Sirona · Charlotte, NC |
| Category | Imaging & diagnostics | Imaging & diagnostics |
| FDA 510(k) | K252934 (Jan 15, 2026); K251072 (Sep 9, 2025) | K262127 (Aug 21, 2026); K260785 (Apr 23, 2026); K253009 (Jan 7, 2026); K250755 (Aug 12, 2025) |
| Cleared for | Concurrent-read detection of periapical radiolucency on permanent teeth in CBCT scans, for patients 22 and older. / Segmentron Viewer: processing and 3D visualization of maxillofacial radiographic images; STL generation for educational purposes only. | Segments anatomy on CBCT scans and intraoral (digital impression) scans for diagnostic review and treatment planning (updated clearance). / Cloud AI service that segments anatomy on CBCT scans and intraoral (digital impression) scans for diagnostic review and treatment planning. / DS Core Detect: concurrent-read detection of permanent teeth that may have periapical radiolucency on CBCT scans already taken for other reasons, adults 22 and older. / DS Core Diagnosis: cloud viewer for reviewing and analyzing dental images and other patient media to support diagnosis. Its Panoramic Curve Proposal feature is for patients 12 and older with permanent dentition. |
| Imaging modalities | CBCT, panoramic, intraoral | bitewing, periapical, panoramic, CBCT, intraoral scan |
| Pricing | From €499/year (Self-serve subscription, 6 or 12 months) | Not published (Bundled with DS Core subscriptions; quote via Dentsply Sirona) |
| Integrations | Dentsply Sirona, Vatech, Planmeca, Carestream | — |
| Best fit | specialist, ortho, oral-surgery | group, dso, specialist |
| Last verified | Oct 25, 2026 | Oct 25, 2026 |
From each vendor's site and the FDA 510(k) database. Diagnocat price: diagnocat.com.
Strengths and limits
- FDA-cleared AI second read on CBCT scans for periapical radiolucency (K252934)
- Lists self-serve plan prices on its website; most dental imaging AI vendors quote only after a demo
- Covers intraoral, panoramic, and CBCT imaging in one platform, with 3D models and STL export (STL cleared for educational use only)
- Newer to the US market than established competitors, with limited domestic clinical validation data
- No US clearance covers its 2D (bitewing, periapical, panoramic) findings
- Self-serve plans are priced in euros, do not connect to the x-ray machine, and unused reports expire at the end of each term
- CBCT integration workflow may require verification with your specific scanner manufacturer
- 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
Next steps
Common questions
What is the difference between Diagnocat and Dentsply Sirona DS Core?
For flagging periapical radiolucency on CBCT, the two clearances are close to identical. Diagnocat (K252934) and DS Core Detect (K253009) both cover permanent teeth in patients 22 and older, as a read alongside the dentist, on scans already taken for another reason. So the choice is about the platform. Diagnocat suits a practice that wants to buy CBCT reads on its own, because it lists self-serve prices (plans with CBCT reports start at €590 for six months). DS Core suits a practice already on Dentsply Sirona imaging, and it adds clearances for CBCT and intraoral-scan anatomy (K260785, K262127). Dentsply Sirona quotes its pricing.
Which is FDA cleared, Diagnocat or Dentsply Sirona DS Core?
Diagnocat: K252934, K251072. Dentsply Sirona DS Core: K262127, K260785, K253009, K250755. Check the scope of each clearance; features outside it are not cleared.