Radiology AI Directory

FDA-cleared profile

Smile Dx®

Cube Click, Inc.

Authorized purpose: Aids dentists reviewing bitewing and periapical radiographs of permanent teeth by detecting/segmenting caries and periapical radiolucencies, identifying restorations and dental anatomy, and measuring mesial/distal bone levels; it does not replace dentist review.

MSK and boneDetection and CADeQuantification and segmentation
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

Authorized purpose: Aids dentists reviewing bitewing and periapical radiographs of permanent teeth by detecting/segmenting caries and periapical radiolucencies, identifying restorations and dental anatomy, and measuring mesial/distal bone levels; it does not replace dentist review.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Aids dentists reviewing bitewing and periapical radiographs of permanent teeth by detecting/segmenting caries and periapical radiolucencies, identifying restorations and dental anatomy, and measuring mesial/distal bone levels; it does not replace dentist review.

Evidence takeaway

Evidence from the reviewed source record: Study type: Both. Cases: 867. Reported sensitivity: Caries: 88.3% (95% CI: 83.5%, 92.6%) , PARL: 86.1% (95% CI: 80.2%, 91.9%). Reader-study cases: 352. Readers: 14. Reader-study sensitivity: Caries: 83.9%, PARL: 89.8%. Reader-study specificity: Caries: 90.2%, PARL: 97.3%

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
Aids dentists reviewing bitewing and periapical radiographs of permanent teeth by detecting/segmenting caries and periapical radiolucencies, identifying restorations and dental anatomy, and measuring mesial/distal bone levels; it does not replace dentist review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

Exact clinical-use normalization from the FDA packet; this text is also the locked corrections value.

Intended users
Licensed dentists
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Intended-user text reported in the exact-submission ACR model card.

Care setting and population
Adult
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.

Workflow role
Segmentation or contouring
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Conservative normalization of explicit wording in an exact-submission source.

Required input
XRAY images or data. Inclusion criteria: Bitewing and periapical radiographs of permanent teeth in patients with permanent adult dentition who are at least 22 years of age; digital and phosphor sensor images; images imported from local computer from a range of manufacturers; supported image formats: jpg, png, tif, tig, dex, gif, bitmap/bmp, and raw
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Conservative normalization of explicit wording in an exact-submission source.

Output and human action
The AI model outputs annotations overlaid on the original radiograph including: contour segmentations for suspected caries, contour segmentations for periapical radiolucencies (PARLs), color-coded lines for mesial and distal bone level measurements (in millimeters and percentages), and segmentations for normal anatomy (enamel, dentin, pulp, bone) and restorations. The dentist can adjust image settings and display or hide the presented annotations.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Clinical output reported in the exact-submission ACR model card.

Limitations
The product does not replace complete dentist review or clinical judgment; family marketing language is not exact-submission performance evidence.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

Exact-product limitations and clinician-review boundary from the FDA packet.

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
K242437
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • Public source
  • Exact FDA submission
  • Checked 2026-09-06

Imaging modality reported in the exact-submission ACR AI Central model card.

Anatomy
Dental/Maxillofacial
  • Public source
  • Exact FDA submission
  • Checked 2026-09-06

Anatomy normalized from explicit exact-submission ACR model-card wording.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-05-14
  • 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
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.

Deployment and data flow
Hybrid
  • 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 2026-08-13

FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

Family commercial access

The official SMILE Dx page presents a product demonstration/contact workflow but does not publish exact integration, hosting, support, or contract terms.

product family · checked 2026-09-06

Exact K242437 interface and current commercial configuration require confirmation.

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
Study type: Both. Cases: 867. Reported sensitivity: Caries: 88.3% (95% CI: 83.5%, 92.6%) , PARL: 86.1% (95% CI: 80.2%, 91.9%). Reader-study cases: 352. Readers: 14. Reader-study sensitivity: Caries: 83.9%, PARL: 89.8%. Reader-study specificity: Caries: 90.2%, PARL: 97.3%
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.

Reported sensitivity
Caries: 88.3% (95% CI: 83.5%, 92.6%) , PARL: 86.1% (95% CI: 80.2%, 91.9%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
95%; 24.7%; 19.9%
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13

Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.

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

Smile Dx® 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 K242437
  • Samplen=867
  • IndependenceIndependence not established

K242437

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-06

Official non-FDA product sources were reviewed for buyer and workflow context, but no exact-submission amount, currency, unit, term, or implementation fee was displayed. A vendor quote remains required.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

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.

Human reviewedStatus
2026-09-07Last searched
27Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Stored exact-submission candidate metadata had zero PubMed and ClinicalTrials.gov identifiers; this metadata screening is not a full paper or registry-record review. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, 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. K242437 FDA decision source

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

    Scope: regulatoryIdentity, purpose, modality, anatomy

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Smile Dx® model card (K242437)

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

    Scope: purpose, modality, intendedUsers, careSetting, output, reportedSensitivity, evidenceSummary, anatomy, evidenceStudies

  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. FDA 510(k) decision material K242437: Smile Dx

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

    Scope: identity, clinical, evidence, implementation

  8. SMILE Dx

    Cube Click - Accessed 2026-09-06

    Scope: buyer_workflow, clinical, implementation

Research history

  1. K242437 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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