Radiology AI Directory

FDA-cleared profile

Denti.AI Detect

Denti.AI Technology, Inc.

Second-reader dental X-ray software that highlights potential tooth findings and helps measure bone levels for dentist review.

MSK and boneDetection and CADe
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Second-reader dental X-ray software that highlights potential tooth findings and helps measure bone levels for dentist review.

Overview status: Source-reviewed overview

Clinical takeaway

Denti.AI Detect adds second-reader highlights and bone-level measurement support for labeled adult dental radiographs; the dental professional remains responsible for the interpretation and care decision.

Evidence takeaway

The FDA package reports separate standalone, bone-measurement, and reader-study endpoints. A 24-reader study reported aided wAFROC 0.809 versus 0.784 unaided; this reader-study result is distinct from the standalone detection and bone-measurement endpoints.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Second-reader CADe support for detecting/highlighting caries and periapical radiolucency and for measuring mesial and distal bone levels on extraoral and intraoral 2D dental radiographs in adults aged 22 years and older without remaining primary dentition.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Dental professionals, comprising dentists and dental specialists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Dental radiograph interpretation by dental professionals; the FDA packet does not specify a narrower facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Second-reader CADe detection/highlighting plus post-processing bone-level measurement support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Extraoral and intraoral 2D dental radiographs, including bitewing, periapical, and panoramic images, from patients aged 22 years and older without remaining primary dentition; listed formats include JPEG, JPG, TIFF, TIF, PNG, BMP, and DICOM.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Highlighted ROIs for caries and periapical radiolucency and mesial/distal bone-level measurements for each tooth, with DICOM secondary-capture/PDF reporting described in the device comparison.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The device is an adjunct and does not replace complete clinician review or clinical judgment using the image, patient history, and other relevant information; use is limited to patients aged 22 years and older without remaining primary dentition. The periapical CEJ-Bone specificity acceptance criterion was the one listed exception in the bone-measurement study.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K230144
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Teeth and dental/maxillofacial structures
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-10-06
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
The FDA packet describes a cloud-based software-only device accepting the listed image formats and returning a PDF report and DICOM secondary capture to PACS; exact PACS interface versions and local compatibility are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
On-cloud
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Denti.AI Detect; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
FDA packet: stand-alone caries/periapical-radiolucency testing used 709 images from 6 U.S. sites with three independent dentists and achieved across-category wAFROC AUC 0.737 (95% CI 0.713-0.761) against a prespecified 0.6 lower-bound threshold. Bone-measurement testing used 193 images from 9 U.S. sites with three independent dentists: bitewing CEJ-Bone sensitivity/specificity 98.1%/93.0%, periapical CEJ-Bone 98.2%/88.5%, periapical CEJ-Root 96.9%/92.2%, and extraoral CEJ-Bone-Root 91.6%/84.3%, with task-specific MAEs. A 24-reader, 154-image MRMC study reported aided wAFROC 0.809 versus unaided 0.784 (difference 0.025, p=0.029).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Bone-measurement endpoints: bitewing CEJ-Bone 98.1% (95% CI 96.0%-99.5%); periapical CEJ-Bone 98.2% (96.2%-99.7%); periapical CEJ-Root 96.9% (94.2%-99.0%); extraoral CEJ-Bone-Root 91.6% (89.6%-93.6%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

These are separately labeled bone-measurement endpoints; the caries/periapical stand-alone detection result is wAFROC AUC, and MAE/reader-study endpoints remain distinct.

Reported specificity
Bone-measurement endpoints: bitewing CEJ-Bone 93.0% (95% CI 88.7%-96.7%); periapical CEJ-Bone 88.5% (82.8%-93.4%); periapical CEJ-Root 92.2% (87.9%-96.0%); extraoral CEJ-Bone-Root 84.3% (70.8%-95.8%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

These are separately labeled bone-measurement endpoints; they are not overall CADe detection specificity.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Denti.AI Detect regulatory performance study summary

  • DesignStand-alone performance and reader study (ACR AI Central category)
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K230144
  • Samplen=902
  • Sites15
  • IndependenceIndependence not established

K230144

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

No public price or quote for the exact K230144 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-09

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The exact-identifier FDA recall query returned no native recall record for K230144. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-09

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-09Last searched
25Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K230144: Denti.AI Detect

    U.S. Food and Drug Administration - Published 2023-10-06 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. Denti.AI Detect model card (K230144)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K230144

    U.S. Food and Drug Administration - Accessed 2026-09-09

    Scope: postmarketSafety

Research history

  1. K230144 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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