- What it does: Denti.AI combines FDA-cleared 2D radiograph analysis (Detect, for caries and periapical radiolucency) and auto-charting with documentation tools: an AI scribe for clinical notes and hands-free voice perio charting. The company says it serves 10,000+ dental professionals in the US and Canada.
- Regulatory: 2 FDA 510(k) clearances (K230144, K222054)
- Pricing: Not published (Per-product plans; quote via sales)
- 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 |
|---|---|---|---|
| K230144 | Denti.AI Detect | Oct 6, 2023 | Denti.AI Detect: second-reader detection of caries and periapical radiolucency on intraoral and extraoral 2D radiographs. |
| K222054 | Denti.AI Auto-Chart | Nov 22, 2022 | Denti.AI Auto-Chart: detects dental structures and restorations on intraoral and extraoral 2D radiographs to produce charting data. |
Capabilities
Imaging modalities: bitewing, periapical, panoramic.
- Detect: second-reader detection of caries and periapical radiolucency (FDA-cleared)
- Auto-Chart: pushes detected conditions and treatment codes into the PMS (FDA-cleared)
- Scribe: records the patient conversation and drafts clinical notes from custom templates
- Voice Perio: hands-free periodontal charting
- Patient education reports
- Two FDA clearances covering detection (K230144) and charting (K222054)
- One vendor for imaging AI plus documentation (scribe, voice perio)
- Also licensed by Health Canada
- Detect's clearance covers caries and periapical radiolucency only, a narrower finding list than some competitors
- Scribe and Voice Perio are documentation tools, not covered by the imaging clearances
What we have not verified
We have not used Denti.AI in a live practice. Vendor statistics (time saved, revenue lift) are the company's own claims and have not been independently verified.
Common questions
Is Denti.AI FDA cleared?
Yes. Denti.AI holds 2 FDA 510(k) clearances: K230144 (Oct 6, 2023) for denti.AI Detect: second-reader detection of caries and periapical radiolucency on intraoral and extraoral 2D radiographs.; K222054 (Nov 22, 2022) for denti.AI Auto-Chart: detects dental structures and restorations on intraoral and extraoral 2D radiographs to produce charting data.. Features outside those indications are not covered by the clearance.
How much does Denti.AI cost?
Denti.AI does not publish pricing; it is quoted by sales (Per-product plans; quote via sales). Denti.AI has a pricing page, but it requires a form to see plans.