- CBCT (cone beam computed tomography) is a 3D x-ray scan of the teeth, jaws, nerve canals, sinuses and airway, taken in one rotation of a cone-shaped beam around the head.
- Dose: RadiologyInfo puts a typical dental CBCT at about 0.18 mSv, versus 0.005 mSv for a dental x-ray, 0.025 mSv for a panoramic and 1.2 mSv for a medical head-and-neck CT.
- Not a routine scan: the 2026 ADA/AAOMR recommendations reserve CBCT for justified indications such as implant planning, third molars near the nerve, TMJ bone changes and endodontic cases that 2D images can't resolve. It is not recommended for finding cavities.
- AI for CBCT: at least 8 products hold FDA 510(k) clearances for CBCT software, from Overjet, Pearl, Diagnocat, Dentsply Sirona, Relu, Orca Dental AI and Velmeni. Most segment or label anatomy; two, from Diagnocat and Dentsply Sirona, cover detecting a disease finding (periapical radiolucency).
CBCT stands for cone beam computed tomography. In dentistry it is an x-ray scanner that rotates once around the patient’s head with a cone-shaped beam and turns the captured images into a 3D view of the teeth, jawbone, nerve canals, sinuses and airway. Dentists, oral surgeons, endodontists and orthodontists use it when a regular 2D x-ray can’t show what they need, most often for implant planning, impacted teeth, jaw joint problems and difficult root canal cases. It uses more radiation than standard dental x-rays and much less than a medical CT, which is why professional guidance treats it as a scan for specific questions rather than a routine one.
The first half of this page covers the scan itself for patients and front-office staff. The second half covers AI software that analyzes CBCT scans, including which products hold FDA clearances and what those clearances cover.
How a CBCT scan works
The FDA describes dental CBCT as a variation of traditional CT: the machine rotates around the patient, capturing data with a cone-shaped x-ray beam, and the data are reconstructed into a 3D image of the teeth, mouth, jaw, neck, and ears, nose and throat region.
According to RadiologyInfo, the patient information site run by the American College of Radiology and the Radiological Society of North America:
- The x-ray source and detector sit on opposite sides of a rotating arm. One rotation produces roughly 150 to 200 2D images, which software combines into a 3D volume.
- You sit or lie down depending on the machine, and hold still while it rotates 360 degrees or less.
- A full-volume scan takes about 20 to 40 seconds. A regional scan of part of the upper or lower jaw takes less than 10 seconds.
- There is no special preparation. You remove metal items such as jewelry, glasses, hairpins and removable dental work, and you tell the office if you might be pregnant.
The dentist can then scroll through the volume in any plane, measure bone height and width, follow the nerve canal through the jaw and look at a tooth’s roots from the side, which a flat x-ray can’t show.
CBCT vs. dental x-rays vs. medical CT
| Dental x-ray (bitewing, periapical) | Panoramic x-ray | Dental CBCT | Medical CT (head and neck) | |
|---|---|---|---|---|
| Image | 2D, a few teeth | 2D, whole mouth in one strip | 3D volume of a region or the whole face | 3D, wide field, strong soft-tissue detail |
| Typical effective dose | 0.005 mSv | 0.025 mSv | 0.18 mSv | 1.2 mSv |
| Same as natural background for about | 1 day | 3 days | 22 days | 5 months |
| Where it’s done | Dental chair | Dental office | Dental office, specialist or imaging center | Hospital or imaging center |
Dose figures are RadiologyInfo’s approximate effective doses. Real doses vary with the machine, the settings and the size of the scanned area (the field of view). A small scan of two or three teeth for a root canal case uses less radiation than a large scan of both jaws for surgery planning, which is why the FDA tells dentists to choose exposure settings based on the clinical question, patient size and area scanned.
The trade-off against medical CT is soft tissue. RadiologyInfo notes that cone beam CT does not provide the full diagnostic information of conventional CT for muscles, lymph nodes, glands and nerves, while it does have lower radiation exposure. CBCT shows bone, teeth and air spaces well.
What dentists use CBCT for
The FDA lists implant planning, abnormal teeth, evaluation of the jaws and face, cleft palate assessment, root canal diagnosis and dental trauma among the clinical uses. RadiologyInfo adds orthodontic treatment planning, impacted teeth, TMJ disorders, jaw tumors, cephalometric analysis and reconstructive surgery. By specialty:
- Implants. The bone’s height, width and density at the planned site, and the distance to the nerve canal and sinus floor. The AAOMR’s 2012 position statement recommended cross-sectional imaging for all implant sites and named CBCT the method of choice.
- Endodontics (root canals). Extra canals, root fractures, resorption and infection that doesn’t show on a periapical x-ray, usually with a small field of view.
- Oral surgery. Lower wisdom teeth whose roots sit near the inferior alveolar nerve, impacted canines, cysts and trauma.
- Orthodontics. Impacted teeth, facial asymmetry, root position and planning for temporary anchorage devices (mini-implants). The AAOMR’s 2013 orthodontic statement says CBCT use should be justified case by case.
- TMJ. Bone changes in the jaw joint. MRI remains the reference for the disc and other soft tissue.
- Airway and sinuses. CBCT captures the nasal space, sinuses and upper airway. A CBCT shows the shape of the airway at one moment, which describes anatomy; it is not a sleep test.
When CBCT is appropriate: ADA, AAOMR and AAE guidance
Three sets of current guidance from US professional bodies say much the same thing: examine the patient first, use CBCT when lower-dose imaging can’t answer the question, and keep the scan as small as the question allows.
ADA and AAOMR, 2026. In January 2026 the ADA and the American Academy of Oral and Maxillofacial Radiology co-published consensus recommendations on patient selection for 2D radiography and CBCT, replacing the 2012 ADA/FDA guidance. The panel issued consensus recommendations rather than formal guidelines because of limits in the evidence. Points that bear on CBCT:
- A history and clinical exam come first, prior images should be reviewed, and CBCT in particular should be used judiciously to limit cumulative radiation.
- CBCT is not supported for detecting caries (cavities).
- For implants, a panoramic can be used for an initial look, but 3D assessment with CBCT is recommended for presurgical planning.
- For third molars, routine screening is not recommended, and a panoramic is the first image. CBCT should be considered when the panoramic shows signs of higher risk to the inferior alveolar nerve, such as roots below the canal or a diverted canal, and only if the result will change the treatment decision.
- For the TMJ, CBCT is recommended to evaluate the bony parts of the joint. MRI is the reference standard for soft-tissue problems such as disc displacement.
- In orthodontics, low-dose CBCT is the recommended modality for assessing facial asymmetry, and CBCT can aid mini-implant site selection, weighed against the added dose.
- In endodontics, small field-of-view CBCT should be considered when disease persists after treatment, and CBCT is the modality of choice for suspected vertical root fractures when the exam and intraoral x-rays are inconclusive.
- The dentist who orders or uses a CBCT is responsible for interpreting the whole scanned volume, including findings outside the area of interest. The panel recommends referring the scan to an oral and maxillofacial radiologist for complex cases or when the dentist lacks the expertise.
AAE and AAOMR, endodontics. The American Association of Endodontists and the AAOMR published a 2025 update of their joint CBCT statement in January 2026, replacing the 2015 version. The AAE’s announcement says it condenses the recommendations to 12, calls for selective rather than routine use, adopts the “as low as diagnostically acceptable” dose principle, discusses AI as an aid to image interpretation, and no longer recommends lead aprons and thyroid collars for CBCT, though state requirements still apply.
FDA. The FDA’s dental CBCT page asks dentists to justify each exam, consider alternatives with less or no radiation, check the patient’s imaging history to avoid duplicate scans, and take extra care with children and young adults, who are more sensitive to radiation. FDA’s pediatric definition runs from birth through age 21.
The underlying rule dates back to the ADA Council on Scientific Affairs’ 2012 advisory statement: prescribe CBCT only when the expected diagnostic yield will benefit patient care, improve safety or improve clinical outcomes significantly.
What a CBCT scan costs
The scan fee varies by office, region and the size of the scan, and coverage depends on the dental plan and the reason for the scan. We did not find a published national price from a primary source, so ask the office for its fee and get a pre-treatment estimate from the insurer before the scan if cost matters.
AI analysis of CBCT scans
A CBCT volume contains hundreds of image slices, and the dentist is responsible for all of it. That is the job AI vendors target: software that segments the teeth and jaws into 3D models, traces the nerve canal, labels the sinus and airway, flags possible disease and drafts a report. Most of the CBCT software clearances in our list of FDA-cleared dental AI companies were issued in 2025 and 2026.
FDA-cleared CBCT AI products
The table lists FDA 510(k) clearances for software that analyzes dental CBCT, from the FDA database and the decision documents (checked October 2026). The “what it is cleared for” column paraphrases each clearance’s indications for use; marketing pages often describe more features than the clearance covers.
| Product | Company | 510(k) | Decision date | What it is cleared for |
|---|---|---|---|---|
| Overjet CBCT Assist | Overjet | K251514 | Dec 5, 2025 | AI segmentation, automated or user-drawn measurements, and 2D/3D views of dental and craniomaxillofacial CBCT. The decision summary says it labels teeth, anatomy and prior work such as implants, root canal fillings, crowns and fillings. |
| Second Opinion 3D | Pearl | K243989 | May 23, 2025 | Identifies and marks anatomy on CBCT: teeth, maxilla, mandible, inferior alveolar canal and mental foramen, maxillary sinus, nasal space and airway. Patients 12 and older, as a concurrent and second reader. |
| Diagnocat | DGNCT, LLC | K252934 | Jan 15, 2026 | Computer-aided detection of periapical radiolucency on permanent teeth in CBCT, as a second read, for patients 22 and older. Only for scans already taken for a clinical reason. |
| Segmentron Viewer | DGNCT, LLC | K251072 | Sep 9, 2025 | Viewing and 3D visualization of CBCT with automated, editable segmentation of teeth, pulp and maxillofacial anatomy. STL export is for educational purposes only. |
| DS Core Detect | Dentsply Sirona | K253009 | Jan 7, 2026 | Concurrent-read detection of permanent teeth that may have periapical radiolucency on CBCT, for adults 22 and older. Only for scans already taken for other reasons. |
| DS Core CBCT Anatomy | Dentsply Sirona | K260785, K262127 | Apr 23, 2026; Aug 21, 2026 | Cloud API that segments teeth, jaws and the inferior alveolar nerve canal on CBCT, proposes a panoramic curve, and registers CBCT to intraoral scans. Patients 12 and older. |
| Relu Creator | Relu | K233925 | Jun 13, 2024 | Management and analysis of CBCT and intraoral scan images; the decision summary describes 3D segmentation and registration for implant, orthodontic and surgical planning. |
| Relu Cloud | Relu | K252708 | Apr 10, 2026 | Management, transfer and analysis of oral and maxillofacial images, including design input for dental solutions. |
| CephX3D | Orca Dental AI | K252538 | Mar 5, 2026 | Analysis of dental and craniomaxillofacial images; the summary describes AI segmentation of the mandible, maxilla, each tooth and the inferior alveolar nerve, with measurements and STL export. Patients 12 and older. |
| VELMENI for Dentists (V4D) 3D | Velmeni | K254096 | Jul 23, 2026 | Concurrent-read detection of anatomy on CBCT: maxilla and cranium, mandible, mandibular canal, TMJ, maxillary sinus, teeth and airway. Patients 15 and older. |
| X-Guide Surgical Navigation System | X-Nav Technologies | K232148 | Feb 21, 2024 | Planning and navigation for dental implant placement and endodontic access. This clearance added machine-learning segmentation of anatomy on maxillofacial CT and intraoral scans. |
Our dental AI FDA clearance tracker lists these alongside the 2D radiograph clearances and is updated as new decisions post.
What these tools do in practice
- Segmentation. Splitting the volume into separate 3D objects: each tooth, the upper and lower jaw, the pulp, the nerve canal. This is the core of Overjet CBCT Assist, Segmentron Viewer, DS Core CBCT Anatomy, Relu and CephX3D. A segmented model can be measured, rotated and exported to planning or aligner software.
- Nerve canal tracing. Pearl, Dentsply Sirona, Orca and Velmeni include the inferior alveolar nerve or mandibular canal in their cleared outputs. This matters most for implant and lower wisdom tooth planning, where the distance from the nerve sets the safe depth.
- Airway and sinus labeling. Pearl’s and Velmeni’s clearances include the airway, and both include the maxillary sinus. These are anatomy labels; neither clearance covers diagnosing sleep apnea or sinus disease.
- Finding detection. Diagnocat’s K252934 and Dentsply Sirona’s DS Core Detect (K253009) are the only clearances in the table that cover detecting a disease finding (periapical radiolucency, the dark area at a root tip that often signals infection). The others identify anatomy or support planning. We compare the two in Diagnocat vs DS Core Detect.
- Reports. Diagnocat’s website advertises radiology, implant and orthodontic reports and says it covers more than 60 conditions in 3D. Its footer notes that features and regulatory clearance vary by country, and its FDA clearances cover the two items in the table. Ask any vendor which of its features sit inside a US clearance.
For how Overjet and Pearl compare on their 2D radiograph clearances, see Overjet vs. Pearl: what the FDA letters say. For a head-to-head of profiles, see Diagnocat vs. Overjet.
Limits to know before buying
- Clearance scope is narrow. A 510(k) covers the indications in the letter. Pearl’s 3D clearance marks anatomy and does not cover detecting pathology on CBCT; Diagnocat’s detection clearance covers one finding on permanent teeth in adults 22 and older.
- The dentist still reads the whole scan. The clearances describe these products as aids to review, diagnosis and planning, and several state outright that they do not replace the clinician’s review or judgment. The 2026 ADA/AAOMR recommendations put responsibility for incidental findings across the full volume on the dentist who orders or uses the scan. Software that labels the teeth and nerve canal will not tell you about a lesion in the sinus or the cervical spine unless it is cleared to do so.
- AI does not justify the scan. Diagnocat’s indications say it may be used only after a dentist has independently decided CBCT is necessary. Buying CBCT software is not a reason to take more scans.
- Evidence is still thin. The 2026 ADA/AAOMR paper notes that clinical use of AI remains limited and calls for standardized performance metrics and better datasets. Ask vendors for the validation study in their 510(k) summary and whether it used scans from your machine type.
- Workflow fit. Most of these products are cloud services that receive DICOM files. Check that your CBCT unit exports in a format the vendor supports, how scans are uploaded, and whether results come back into your imaging software. Of the vendors in the table, only Diagnocat publishes prices (self-serve, €990 a year with CBCT reports, per diagnocat.com/us/subscribe); the others quote through sales. Our guide to how dental AI imaging tools charge covers the common pricing models.
Frequently asked questions
What is a CBCT scan at the dentist?
A CBCT scan is a 3D x-ray. The machine rotates around your head once, usually while you sit or stand still, and software rebuilds the images into a 3D volume of your teeth, jawbone, nerve canals and sinuses. Dentists use it when regular 2D x-rays can't answer the clinical question.
What is the difference between CBCT and a regular CT scan?
CBCT uses a cone-shaped beam and captures the whole region in one rotation, while medical CT uses a fan-shaped beam on a larger scanner you lie inside. RadiologyInfo lists about 0.18 mSv for a dental CBCT and 1.2 mSv for a head-and-neck CT. CBCT shows bone and teeth well but gives much less soft-tissue detail than medical CT.
How much radiation is a dental CBCT?
RadiologyInfo, run by the ACR and RSNA, gives about 0.18 mSv for a cone beam CT, which it compares to 22 days of natural background radiation. The real dose depends on the size of the area scanned and the machine settings, so a small scan of a few teeth uses less than a full-skull scan.
When is a CBCT scan necessary?
The ADA and AAOMR say CBCT should follow a clinical exam and be used only when 2D imaging can't give the needed information. Their 2026 recommendations list presurgical implant planning, third molars that look close to the nerve on a panoramic, bony TMJ problems and some root canal cases. They do not support CBCT for detecting cavities or for routine screening.
How long does a CBCT scan take?
RadiologyInfo says a full-volume scan typically takes 20 to 40 seconds and a scan of one region of the upper or lower jaw takes under 10 seconds. There is no special preparation beyond removing metal items such as jewelry, glasses and removable dental work.
Can AI read a CBCT scan?
AI software can segment teeth, jaws and the nerve canal on a CBCT, label anatomy such as the sinus and airway, and produce reports. Several of these tools hold FDA 510(k) clearances, but each clearance covers specific tasks and none replaces the dentist, who remains responsible for interpreting the whole scan.
Which CBCT AI is FDA cleared?
As of October 2026, FDA-cleared CBCT software includes Overjet CBCT Assist, Pearl Second Opinion 3D, Diagnocat (periapical radiolucency second read) and its Segmentron Viewer, Dentsply Sirona DS Core Detect (periapical radiolucency) and DS Core CBCT Anatomy, Relu Creator and Relu Cloud, Orca Dental AI CephX3D, and Velmeni V4D 3D. Check the FDA 510(k) database for each clearance's exact indications.
Sources
- FDA: Dental cone-beam computed tomography
- RadiologyInfo (ACR/RSNA): Dental cone beam CT
- RadiologyInfo (ACR/RSNA): Radiation dose in x-ray and CT exams
- ADA: X-rays/radiographs (oral health topic)
- Benavides et al. ADA and AAOMR patient selection for dental radiography and CBCT: clinical recommendations. JADA 2026;157(1):20-35
- ADA Council on Scientific Affairs. The use of cone-beam computed tomography in dentistry: an advisory statement. JADA 2012
- AAOMR position statement on selection criteria for radiology in dental implantology with emphasis on CBCT (2012)
- AAOMR clinical recommendations regarding use of CBCT in orthodontics (2013)
- AAE and AAOMR joint position statement: use of CBCT in endodontics 2025 update. J Endod 2026
- AAE press release: AAE and AAOMR release joint position statement on the use of CBCT in endodontics (January 2026)
- FDA 510(k) K251514: Overjet CBCT Assist
- FDA 510(k) K243989: Pearl Second Opinion 3D
- FDA 510(k) K252934: Diagnocat
- FDA 510(k) K251072: Segmentron Viewer (Diagnocat)
- FDA 510(k) K260785: DS Core CBCT Anatomy
- FDA 510(k) K233925: Relu Creator
- FDA 510(k) K252708: Relu Cloud
- FDA 510(k) K252538: CephX3D (Orca Dental AI)
- FDA 510(k) K254096: VELMENI for Dentists (V4D) 3D
- FDA 510(k) premarket notification database
Independent. We verify regulatory claims against the FDA 510(k) database and link every filing. Found an error? Email [email protected]; corrections are logged on our editorial policy page.