- What it does: Better Diagnostics holds two recent FDA clearances: Caries Assist (2025) for concurrent-read caries detection, and Dental Assist (2026) for bone-level measurement plus marking of suspected findings such as calculus and periapical radiolucency.
- Regulatory: 2 FDA 510(k) clearances (K260851, K241725)
- Pricing: From $149 (Per location / month (via Open Dental))
- Best fit: solo, group
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 |
|---|---|---|---|
| K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0 | Jul 15, 2026 | Measures mesial and distal bone levels and marks suspected findings (marginal discrepancy, calculus, periapical radiolucency and more) on bitewing and periapical radiographs. |
| K241725 | Better Diagnostics Caries Assist (BDCA) Version 1.0 | Mar 11, 2025 | Concurrent-read caries detection on bitewing and periapical radiographs, patients 18 and older. |
Capabilities
Imaging modalities: bitewing, periapical.
- Two clearances in 18 months, including a 2026 multi-finding clearance (K260851)
- Newer entrant with little public information on integrations or US adoption
What we have not verified
We have not evaluated Better Diagnostics. Integration and pricing details were not publicly available at last verification.
Common questions
Is Better Diagnostics FDA cleared?
Yes. Better Diagnostics holds 2 FDA 510(k) clearances: K260851 (Jul 15, 2026) for measures mesial and distal bone levels and marks suspected findings (marginal discrepancy, calculus, periapical radiolucency and more) on bitewing and periapical radiographs.; K241725 (Mar 11, 2025) for concurrent-read caries detection on bitewing and periapical radiographs, patients 18 and older.. Features outside those indications are not covered by the clearance.
How much does Better Diagnostics cost?
Better Diagnostics pricing starts at about $149 (Per location / month (via Open Dental)). Open Dental sells BetterDiagnostics AI image analysis natively in its Imaging Module for $149/month/location, billed on the Open Dental statement. Pricing for other systems is not published.
What does Better Diagnostics integrate with?
Better Diagnostics lists integrations with Open Dental (native, Imaging Module). Confirm compatibility with your exact practice management and imaging versions before signing.
Sources
Corrections and updates
- 2026-10-21: Added published pricing: $149/month/location through Open Dental's native integration.