Five Dental AI Tools Now FDA-Cleared For CBCT Review

Pearl launched Second Opinion 3D for general dentists on September 3, 2026. The launch puts a spotlight on dental AI CBCT clearances, now held by five companies. VELMENI became the fifth in July. Their cleared uses differ, from mapping anatomy to flagging possible periapical radiolucencies. Here is what each clearance covers.

TL;DR

• Pearl launched Second Opinion 3D for general dentists in the U.S. and Canada in September 2026

• VELMENI's July 2026 clearance brings FDA-cleared CBCT AI to five companies

• Pearl, Overjet, and VELMENI identify, segment, or measure anatomy and restorations

• Dentsply Sirona and Diagnocat flag possible periapical radiolucencies for clinician review

What Does FDA Clearance Mean For CBCT AI Software?

FDA clearance confirms a defined use. Each clearance covers the uses written in its record. Dentists who read the clearance record know exactly what the software is allowed to claim.

This article covers 3D CBCT products only. AI for 2D radiographs, caries, and periodontal bone loss appears in the dental imaging AI overview.

All five products in this article reached the U.S. market through the 510(k) pathway. A 510(k) clearance means the FDA found the device substantially equivalent to a cleared predicate. Premarket approval is a separate, stricter pathway for higher-risk devices. "FDA cleared" is the accurate label for these tools.

The FDA keeps a public list of AI-enabled medical devices. Devices on the list have met the agency's premarket requirements for their intended use. Each entry links to the official clearance record and summary.

Why Does The Indication For Use Matter?

The indication for use is the single most useful line in any clearance record. It names the image type, the patient population, and the task the software performs.

Marketing pages often describe a wider product. Pearl, for example, describes extra AI flags in Second Opinion 3D. These cover carotid artery calcifications, impacted teeth, and sinus radiopacities. Oral Health Group reported that Pearl lists those features as available in Canada. They still await regulatory approval in other markets.

The FDA product code adds another clue. Diagnocat and DS Core Detect sit under code MYN. That is the medical image analyzer category used for computer-aided detection. Overjet CBCT Assist sits under code QIH, which covers automated image processing software. A dentist can see this split in the FDA 510(k) database in under a minute. It signals whether a product flags a finding or organizes anatomy.

Which Five Dental AI Systems Have FDA Clearance For CBCT?

Five dental AI CBCT products received FDA 510(k) clearance between May 2025 and July 2026. The table sorts them by clearance date. The last column shows what each product does with a scan.

Dentsply Sirona holds a second CBCT clearance as well. The FDA AI device list shows DS Core CBCT Anatomy, cleared April 23, 2026. That product sits in the processing category alongside Overjet CBCT Assist.

#1. Pearl Second Opinion 3D

Pearl cleared the first product in this group on May 23, 2025. Its clearance covers anatomy identification, and its commercial launch added workflow tools around that core.

The cleared AI identifies the mandible, maxillary complex, nasal space, airway, inferior alveolar nerve canal, and individual teeth. Pearl launched Second Opinion 3D in the U.S. and Canada on September 3, 2026. The viewer color-codes each structure. Users can hide or highlight anatomy, rotate the volume, adjust opacity, and measure length.

Two workflow additions stand out. Dentists can request a report from a licensed oral and maxillofacial radiologist inside the software. The platform also turns CBCT findings into documentation for insurance claims.

Pearl also lists pathology flags for TMD, carotid artery calcifications, impactions, periapical radiolucencies, and sinus radiopacities. Pearl says these flags are live in Canada and pending in other markets. A U.S. dentist should treat them as outside the cleared use. This review of Pearl AI covers the company's 2D platform in more depth.

#2. Overjet CBCT Assist

Overjet's clearance adds measurement to anatomy identification. The FDA record shows a decision date of December 5, 2025.

Overjet describes CBCT Assist as software that identifies and measures anatomical and restorative structures. Restorative structures in a CBCT volume include existing crowns, implants, and root canal fillings. Automated labels on these items speed up orientation in a crowded scan.

Measurement carries the most clinical weight where millimeters decide the plan. Implant sites near the mandibular canal are the clearest example. A pre-measured volume still needs a clinician to confirm every landmark before surgery. The product code for CBCT Assist is QIH, the image processing category. It organizes and quantifies what is in the scan. It does not carry a detection claim for disease.

#3. Dentsply Sirona Smart View – Detect

This product targets one specific finding. It highlights teeth with possible periapical radiolucencies, often shortened to PARLs.

The FDA cleared DS Core Detect on January 7, 2026. Dentsply Sirona launched it as Smart View – Detect on May 4, 2026. The company states that the feature does not provide a diagnosis. It marks areas for the clinician to review.

Dentsply Sirona cites an internal multi-reader, multi-case study. Clinicians using the tool raised tooth-level PARL detection sensitivity aby bout 46% relative to unaided review. The company reports no meaningful rise in false positives. This is a manufacturer study, and independent replication would carry more weight.

The feature runs inside DS Core and needs a Standard or Advanced subscription. It works with Orthophos S, Orthophos SL, and Axeos units. Fields of view from 5×5 to 17×11 are supported, including older scans moved from Sidexis 4.

A PARL is a radiographic sign. It can reflect apical periodontitis, a cyst, a healing defect, or normal anatomy near the apex. Pulp testing, symptoms, and history still decide whether a tooth has a periapical infection.

#4. Diagnocat

Diagnocat shares the PARL focus with Dentsply Sirona. Its indication adds tighter limits on when and for whom the software applies.

The FDA cleared Diagnocat oJanuary 1515, 2026. The cleared use is a second-reading aid on previously acquired CBCT scans. It covers permanent teeth in patients aged 22 or older. The indication states that the decision to take a CBCT must be made independently of the software.

That last clause separates interpretation from acquisition. The software may assist once a scan exists. It cannot justify taking the scan. A second-reader design also sets the order of work. The clinician reads the volume first, then checks the AI output against that read.

#5. VELMENI For DENTISTS 3D

VELMENI is the latest company on this list. Its clearance focuses on segmentation and adds a reconstructed panoramic view.

The FDA cleared VELMENI for DENTISTS 3D oJuly 2323, 2026. The software segments teeth, the mandible, the mandibular canal, maxillary sinuses, temporomandibular joints, and the airway. The cleared use covers CBCT scans of patients aged 15 or older with permanent teeth.

VELMENI tested segmentation and labeling on 127 de-identified images from four U.S. dental offices. Its submission named Pearl Second Opinion 3D as the predicate device. The reconstructed panoramic view gives a familiar 2D overview of a 3D volume. A dentist can screen from that view before scrolling individual slices.

How Do These CBCT AI Systems Differ?

The five products fall into four functional groups. Grouping them by function prevents a common misread: that every cleared tool "diagnoses" from a CBCT.

Anatomical Segmentation And Visualization

Segmentation software labels structures so a 3D volume becomes easier to navigate. Pearl Second Opinion 3D and VELMENI for DENTISTS sit here, along with DS Core CBCT Anatomy.

A labeled mandibular canal helps a dentist orient quickly before implant or extraction planning. Color-coded anatomy also helps during patient communication. The label remains a software estimate. The clinician still traces the canal through every relevant slice.

Measurement Of Structures

Measurement tools quantify what segmentation has labeled. Overjet CBCT Assist is the clearest example in this group.

Automated distances and dimensions save time in implant site review and restorative assessment. Accuracy depends on voxel size, patient movement, and scatter from metal restorations. A 2026 systematic review on metal artifacts shows how metal restorations distort CBCT images. Any automated measurement near a crown or implant deserves a manual check.

Detection Of Specific Findings

Detection tools flag one defined class of abnormality for review. Dentsply Sirona Smart View – Detect fits this group.

The practical gain is coverage. A dentist scanning for one implant site may never scroll to the opposite arch's apices. A detection layer pulls attention to every apex in the field of view. Each flag still needs clinical correlation before it enters the chart.

Second-Reader Support

Second-reader tools add a check after the clinician has already read the scan. Diagnocat's indication follows this model.

The order of work protects the clinician's own read. Forming an impression first limits anchoring on the AI output. The software then acts as a safety net for missed periapical findings.

Vendors add new clearances over time, so one brand can move into several groups. Dentists comparing products should line up cleared functions side by side, then compare brands.

What Does The News Mean For Dental Practices?

The clearances widen the choice of CBCT software for general dentists. The clinical rules around each scan stay the same.

AI analysis gives no reason to order a scan. The FDA guidance on dental CBCT still reserves scans for questions other imaging cannot answer. Background on scan types, dose, and cost sits in the CBCT scanning guide.

Each tool assists a licensed clinician. The dentist still reviews the full volume and sets the dental treatment plan. Independent evidence also remains thin. A 2026 systematic review of AI in CBCT implant planning flagged small datasets. It also noted limited external validation.

Practices weighing a purchase should match the cleared indication to their CBCT unit and case mix. A trial on previously read scans shows how the software performs locally. General buying criteria appear in the AI in dentistry guide.

Bottom Line

Dental AI CBCT now covers several product categories under one label. Pearl and VELMENI segment anatomy. Overjet adds measurement. Dentsply Sirona and Diagnocat flag possible periapical radiolucencies, each under its own limits. All five assist a clinician, who remains responsible for the read and the plan. Every vendor conversation should start with one question – What is this software cleared to help the dentist see, measure, or detect?