AI for Dental Practices in 2026: What's FDA-Cleared, What's Hype, and What's Worth Buying

Updated September 14, 2026: we corrected this guide's FDA clearance counts and descriptions against FDA's 510(k) database, fixed VideaHealth's and Diagnocat's clearance details, and replaced unsourced pricing figures.

Dental AI in 2026 splits cleanly into two worlds, and the difference between them matters more than any feature comparison. On one side: FDA-cleared imaging tools that analyze radiographs and suggest clinical findings — regulated medical devices that have been validated for safety and effectiveness. On the other: everything else — front-office automation, patient communication, scheduling, and general-purpose AI — which doesn't need FDA clearance because it isn't making clinical determinations.

Confusing these two categories is the single most common mistake dental practices make when evaluating AI. A tool that analyzes your X-rays and flags caries needs FDA 510(k) clearance. If it doesn't have it, you're either using it off-label or the vendor is making claims they shouldn't. A tool that books appointments or drafts patient emails needs no such clearance, and demanding it would be pointless.

This guide breaks down both worlds: which dental AI tools are actually FDA-cleared, what they detect, real pricing, and a practical framework for evaluating dental AI without falling for marketing. As always, this is informational — verify FDA clearances and compliance directly before deploying any clinical tool.

The two categories of dental AI

Understanding the split is the foundation of every good dental AI decision.

Clinical AI interprets medical images, suggests diagnoses, or supports clinical decisions. This category includes radiograph analysis tools that detect caries, measure bone loss, and identify periapical lesions. Because these tools influence clinical judgment, they're regulated by the FDA as medical devices. The usual pathway is the FDA 510(k), in which the manufacturer shows the device is substantially equivalent to one already legally marketed, typically with performance testing for its stated indications.

Non-clinical AI handles everything that doesn't make clinical determinations: AI receptionists, scheduling agents, recall automation, billing and coding, patient communication, and practice operations. These tools don't need FDA clearance because they aren't interpreting medical images or suggesting diagnoses. General-purpose AI like ChatGPT and Claude fall here too — they're used at thousands of practices for documentation, marketing, and operations with no clearance needed (though they still require HIPAA compliance and BAAs if they touch patient data).

The practical rule: if a tool analyzes your radiographs and suggests clinical findings, it needs FDA clearance. If it doesn't have clearance, that's a red flag for clinical use and audit defense.

The FDA-cleared imaging tools

The field is bigger than most buyer's guides suggest. A search of FDA's 510(k) database in September 2026 turns up dental radiograph AI clearances from at least ten companies. The three with the broadest 2D platforms, Pearl, Overjet, and VideaHealth, get the most attention, and they are covered in detail below. Others with cleared products include Denti.AI, Velmeni, Better Diagnostics, Diagnocat, Orca Dental AI, Adra, and Dentsply Sirona. Every K-number below comes from FDA's database; look up any vendor's clearance yourself before relying on a sales deck.

Pearl

Pearl's Second Opinion is one of the most widely adopted FDA-cleared dental imaging platforms. Its original clearance, K210365 (March 2022), covers detection on bitewing and periapical radiographs, and Pearl has since added a separate 3D clearance. Pearl says more than 29,000 practices have chosen it and that practices "catch 37% more disease." Both figures are vendor-reported; the FDA clearances are independently verifiable.

Pearl's detection coverage includes caries, calculus, periapical findings, and other pathologies. Its design emphasis is real-time chairside assistance: the AI analyzes radiographs during the exam, and the visual overlays help with patient case presentation. Practices specifically value Pearl for reducing interpretation variability between rotating doctors and associates — establishing consistency across recalls and new-patient exams. FDA's database lists eight Second Opinion 510(k) clearances for Pearl:

• Second Opinion (K210365, March 2022): the original detection clearance
• Second Opinion CC (K242522, January 2025): caries detection with outlined regions on bitewing and periapical images, ages 19 and older
• Second Opinion Periapical Radiolucency Contours (K242600, April 2025)
• Second Opinion Pediatric (K243893, May 2025): caries detection on bitewing and periapical images for patients 4 and older with primary or mixed dentition
• Second Opinion BLE (K243230, May 2025): bone level measurements on bitewing and periapical images, ages 12 and older
• Second Opinion 3D (K243989, May 2025): anatomy segmentation on CBCT scans
• Second Opinion CS (K243234, June 2025): caries detection and segmentation on periapical images, ages 12 and older
• Second Opinion Panoramic (K250525, November 2025): suspected caries, periapical radiolucencies, and impacted third molars on panoramic images

Pearl does not publish pricing. Capterra lists a flat-rate starting price of $299/month, and larger organizations get volume pricing. Verify current pricing directly with the vendor. In 2026 Pearl also added Pearl Voice for ambient notes and voice perio charting.

Overjet

Overjet is positioned as clinical intelligence infrastructure rather than just a chairside detection tool. It starts with imaging AI and extends into revenue cycle management, enterprise analytics, and multi-location governance — making it especially popular with DSOs and multi-location groups.

Overjet has the most 510(k) clearances of any dental AI company in FDA's database: twelve between 2021 and August 2026. They cover bone level measurement (Dental Assist, K210187), adult caries (Caries Assist, K212519 and K222746), calculus (K220928), periapical radiolucency (K231678), pediatric caries (K233738), charting (K233590 and K241684), image enhancement (K241681), CBCT (K251514), the Iris imaging system (K253930), and multi-image caries and charting (K261059). When the image enhancement clearance came through in 2024, Overjet described itself as "the first and only dental AI platform that is FDA-cleared to enhance images." The software improves blurry or noisy X-rays.

Overjet's pricing is customized based on practice size, location count, and selected modules, with a demo required for a quote. Its ROI figures are vendor-reported. Two newer developments are worth knowing. Overjet Voice (2026) adds ambient notes and voice perio charting. And Overjet also markets AI utilization-review tools to dental insurers.

VideaHealth

VideaHealth holds four 510(k) clearances. They include Videa Caries Assist (K213795, April 2022), Videa Perio Assist (K223296, February 2023), and Videa Dental Assist (K232384). FDA cleared Dental Assist on December 15, 2023, and VideaHealth announced it on January 3, 2024, as covering more than 30 AI algorithms. The newest, Videa Dental AI (K251002, September 2025), is cleared for bitewing, periapical, and panoramic radiographs of patients 3 and older. It detects findings such as caries, calculus, periapical radiolucency, furcation, and widened periodontal ligament, along with existing restorations and normal anatomy. VideaHealth reports a 119% increase in caries detection and a 20% lift in case acceptance. Both figures are vendor-reported.

VideaHealth's customer list leans toward large DSOs, including Heartland Dental and Aspen Dental. Pilot it alongside Pearl and Overjet, especially if you're a smaller practice. It now also offers Voice Notes and Voice Perio.

Other FDA-cleared dental AI

Several more companies hold clearances. Many are narrower in scope, so check the exact indication:

• Denti.AI: Denti.AI Auto-Chart (K222054, November 2022) and Denti.AI Detect (K230144, October 2023).
• Velmeni: Velmeni for Dentists (K240003, August 2024; K250753, September 2025), an Endo-Perio version (K252953, May 2026), and a 3D version (K254096, July 2026).
• Better Diagnostics: Caries Assist (K241725, March 2025) and Dental Assist (K260851, July 2026).
• Diagnocat (K252934, January 2026): cleared to aid detection of periapical radiolucency on maxillary CBCT scans. It is a 3D detection aid, not a general CBCT segmentation clearance.
• Orca Dental AI: CEPHX cephalometric analysis (K231396, January 2024) and CEPHX3D (K252538, March 2026), for orthodontic workflows.
• Adra: Adravision Perio (K232440, December 2023).
• Dentsply Sirona: DS Core CBCT Anatomy (K260785, April 2026; K262127, August 2026).

What the FDA clearance actually means

It's worth being precise about what "FDA-cleared" does and doesn't mean, because the marketing often blurs it.

FDA 510(k) clearance means FDA agreed the device is substantially equivalent to a legally marketed device for its stated indications. For AI detection software, the submission typically includes standalone performance testing and often a clinical reader study. That's a meaningful bar, and it means the product isn't experimental. It does not guarantee the same performance on your sensors, your patient population, or image types outside the indication.

But clearance is specific to indications. A tool cleared for caries detection in bitewing images is cleared for that — not necessarily for every type of detection in every image type. This is why the scope of each clearance matters more than the raw count (Overjet has twelve 510(k)s and Pearl eight, but several are updates to the same product), and why you should verify the specific K-number and its stated indications at fda.gov before deploying a tool clinically, especially in a multi-location group where audit defense matters.

The clearance also doesn't mean the AI replaces clinical judgment. These are diagnostic aids — they flag findings for the clinician to confirm. The dentist remains responsible for the diagnosis. The AI's value is catching things a tired clinician might miss and standardizing detection across a team, not replacing the dentist's expertise.

Why this category is worth it (and the honest caveats)

Dental imaging AI is arguably the highest-impact AI category for chairside dentistry in 2026, for two distinct reasons.

Diagnostic accuracy. FDA-cleared platforms catch early-stage caries, subtle bone loss, and periapical findings that are easy to miss on a quick read — especially late in a busy day. The consistency benefit is real: AI doesn't get tired, doesn't rush the last appointment before lunch, and applies the same detection threshold to every image.

Case acceptance. This is the underappreciated driver. When a patient can see the AI-highlighted area of decay on their own X-ray, treatment acceptance rises. The visual overlay turns "trust me, you need this filling" into "here's the problem, highlighted." Vendors report significant case acceptance lifts, and while those figures are vendor-reported, the underlying mechanism — patients accepting treatment they can see — is well-established.

The honest caveats:

Subscription fees add up. Few vendors publish prices. Of those that do, Capterra lists Pearl from $299/month, and Denti.AI's bundled "OneStop Clinical" plan (X-ray analysis, AI notes, and voice perio for one location) is $399/month. Enterprise vendors quote by location and module. Get the total for every location and every module you'd actually use, not just the entry price.

Integration must be verified upfront. Pearl, Overjet, and others publish integrations with Dentrix, Eaglesoft, Open Dental, Curve, and Carestream — but specifics vary by PMS version and imaging platform. Do not take integration claims at face value. Confirm your exact PMS version and sensor setup are supported before signing.

Not every practice needs it today. For a single-provider practice where diagnostic variance is already low, the case for imaging AI is weaker than for a multi-provider group with rotating associates. If your bigger problem is the phone (it is for most practices), the better first investment may be front-office AI, with imaging AI as a later clinical layer.

Vendor outcome numbers are vendor-reported. The "37% more disease" (Pearl), "119% increase in caries detection" (VideaHealth), and "10x ROI" (Overjet) figures come from vendors. The FDA clearances are independently verifiable; the outcome percentages are not. Treat them as directionally useful, not gospel.

The non-clinical side: front-office AI

Beyond imaging, a growing share of dental AI handles the work that doesn't touch radiographs — and for many practices, this is the more natural entry point because it solves the daily pain of phone tag, no-shows, and recall gaps.

AI receptionists and scheduling agents answer calls, book appointments, handle reschedules, and manage recall outreach. For practices drowning in phone volume, these can be transformative. One important compliance note: AI receptionists with call recording can trigger wiretap claims in two-party-consent states. Confirm your vendor handles consent properly for your state.

Recall and reactivation automation identifies patients overdue for cleanings or treatment and automates outreach. This directly addresses revenue leakage from patients who fall out of the recall cycle.

Billing and coding AI handles CDT/CPT coding, claims, and revenue cycle management. The major practice management platforms (Dentrix Ascend, Eaglesoft, Open Dental, Curve, Carestream, Planet DDS) are increasingly embedding AI modules for scheduling optimization, no-show prediction, treatment plan presentation, and RCM.

Clinical documentation AI turns voice into perio charts and clinical notes. It doesn't need FDA clearance, but it raises its own questions about accuracy, audio retention, and patient notice. Standalone tools like Bola AI and Kiroku now compete with voice products built into Overjet, Pearl, VideaHealth, and Dentrix Ascend. We compare them in AI dental scribes and voice perio charting.

General-purpose AI (ChatGPT, Claude) handles patient communication drafts, marketing content, insurance documentation, and hiring — with no FDA clearance needed. The critical caveat: if any patient health information is involved, these require HIPAA compliance and a BAA, which the consumer versions of these tools do not provide. (See our guide to what HIPAA compliance means for AI tools for the full picture.)

A practical evaluation framework

How to actually evaluate dental AI without falling for marketing.

Start with your biggest pain point. If your problem is missed diagnoses or inconsistency between providers, start with imaging AI. If your problem is the phone, no-shows, or recall gaps, start with front-office AI. Don't buy imaging AI to solve a scheduling problem.

For clinical tools, verify the FDA clearance. Get the specific K-number and confirm it at fda.gov. Check that the cleared indications match what you actually need (caries detection, bone loss measurement, CBCT segmentation, etc.). For multi-location groups, this is audit defense, not bureaucracy.

Run a real pilot on your own radiographs. Clinical AI evaluations that don't use your actual practice X-rays and your own clinicians' review are almost always misleading. Insist on a 30-60 day pilot measuring detection changes, time savings, case acceptance improvements, and staff comfort. Pilot data — not vendor demos — should drive the decision.

Verify integration with your exact stack. Confirm your specific PMS version, imaging software, and sensor brand are supported. Integration specifics vary, and a tool that doesn't fit your stack creates workflow friction that erases its value.

Confirm HIPAA compliance and BAA. Every AI vendor with access to PHI is a third-party risk that must be governed under a signed Business Associate Agreement, ideally with subcontractor flow-down clauses. This applies to both clinical and non-clinical tools.

Calculate total cost across all operatories. Per-chair pricing looks small until you multiply by your operatory count. Run the full-practice math before committing.

Don't try to solve everything at once. Approach one use case at a time. Train staff properly before full rollout. Overwhelming your clinical team with multiple new AI tools simultaneously is how adoption fails.

How to choose between Pearl, Overjet, and VideaHealth

For the most common decision — picking among the three leading 2D imaging platforms — here's the practical framing.

Pearl is the strong chairside detection platform. It's best for practices that want real-time pathology detection and patient-facing visuals without enterprise analytics. It has clearances across bitewing, periapical, panoramic, and CBCT images, and a third-party listed starting price around $299/month, which makes it one of the more accessible options for solo and small practices.

Overjet is clinical intelligence infrastructure. It's best for groups and DSOs that want imaging AI plus revenue cycle management, analytics, and multi-location governance. It has the most 510(k) clearances in the category, including image enhancement and CBCT. Enterprise pricing, demo required. Also know that Overjet sells claims-review AI to dental insurers.

VideaHealth is built around large DSOs. Its newest clearance covers panoramic images and patients as young as 3. It's best for multi-location groups that want standardized detection plus revenue tools. Smaller practices should compare its quote directly against Pearl's.

The standard DSO shortlist is all three — and the right move is to run the same controlled pilot across all of them on your own radiographs rather than evaluating any one in isolation.

The bottom line

Dental AI in 2026 is real and FDA-cleared for imaging — it's not hype. The cleared imaging tools range from broad 2D platforms like Pearl, Overjet, and VideaHealth to a growing list of narrower clearances, such as Diagnocat for periapical lesions on CBCT and Orca for cephalometrics. They catch disease that's easy to miss, standardize detection across a team, and meaningfully improve case acceptance when patients can see their own findings highlighted. For multi-provider practices and DSOs especially, the case is strong.

But the technology isn't free, not every practice needs it today, and the category split matters enormously. Clinical tools that read your radiographs need FDA clearance — verify it. Non-clinical tools that handle your phones and scheduling don't — but they still need HIPAA compliance if they touch patient data. The practices that win with dental AI are the ones that start with their actual biggest pain point, pilot on their own data, verify the regulatory and compliance details, and roll out one use case at a time rather than chasing every shiny tool at once.

For a directory of dental AI tools — including FDA-cleared imaging platforms and front-office automation — with compliance details and specialty fit, see our solo dental practices page, our AI Medical Imaging & Diagnostics use case page, and our full directory.

This article is informational only and does not constitute medical, legal, or procurement advice. FDA clearances, vendor capabilities, and pricing change frequently, and outcome figures cited are vendor-reported. Always verify FDA 510(k) clearance numbers at fda.gov, confirm HIPAA compliance and BAA availability, and run your own clinical pilot before deploying any AI tool in clinical practice.