Radiology AI Directory

FDA-cleared profile

DS Core Detect

Dentsply Sirona, Inc.

Authorized purpose: Concurrent-read incidental detection of permanent teeth that may be associated with periapical radiolucencies in CBCT data acquired for other reasons.

Detection 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

Authorized purpose: Concurrent-read incidental detection of permanent teeth that may be associated with periapical radiolucencies in CBCT data acquired for other reasons.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Concurrent-read incidental detection of permanent teeth that may be associated with periapical radiolucencies in CBCT data acquired for other reasons.

Evidence takeaway

Evidence from the reviewed source record: FDA testing included standalone and fully crossed MRMC studies. The representative standalone study used 306 CBCTs; high-sensitivity operating-point results were sensitivity 0.78 (95% CI 0.74-0.81) and specificity 0.93 (0.92-0.94), while standard-sensitivity results were 0.66 (0.62-0.70) and 0.97 (0.97-0.98). The MRMC study used 11 US readers and reports unaided/aided model-based AUC 0.415/0.639, tooth-level sensitivity 0.421/0.649, and specificity 0.962/0.946. The FDA ground truth was a consensus reference for the standalone study and reader performance was evaluated separately.

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
Concurrent-read incidental detection of permanent teeth that may be associated with periapical radiolucencies in CBCT data acquired for other reasons.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Trained and licensed dentists
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Dental clinical workflow through a dental image viewer; adult patients aged 22 years or older with permanent teeth
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Concurrent-read incidental PARL detection support with user confirmation or rejection of flagged teeth
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Existing CBCT data from adult patients aged 22 years or older with permanent teeth; the data must already have been acquired for other reasons and is viewed through the dental image viewer.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
A list of teeth that may potentially have periapical radiolucency and a corresponding PARL map; the dentist can confirm or reject each flagged tooth. Two operating points are available: Standard sensitivity and High sensitivity.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Incidental use only on already-acquired CBCT; not a replacement for complete dentist review or clinical judgment and not an indication to obtain X-ray images. The FDA population is adults aged 22 years or older with permanent teeth.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K253009
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CBCT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Permanent teeth and periapical dental structures
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-01-07
  • 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
Cloud-based SaMD accessed by a dental practitioner through a dental image viewer, where CBCT images and device results are viewed together. The FDA packet does not specify PACS, RIS, EHR, or DICOM interface details.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

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 2026-09-08

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 2026-09-08

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

ACR exact-submission catalog context

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

exact submission ยท checked 2026-09-08
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 testing included standalone and fully crossed MRMC studies. The representative standalone study used 306 CBCTs; high-sensitivity operating-point results were sensitivity 0.78 (95% CI 0.74-0.81) and specificity 0.93 (0.92-0.94), while standard-sensitivity results were 0.66 (0.62-0.70) and 0.97 (0.97-0.98). The MRMC study used 11 US readers and reports unaided/aided model-based AUC 0.415/0.639, tooth-level sensitivity 0.421/0.649, and specificity 0.962/0.946. The FDA ground truth was a consensus reference for the standalone study and reader performance was evaluated separately.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
78% (95% CI: 74%, 81%)
  • 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
93% (95% CI: 92%, 94%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

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

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

DS Core 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 K253009
  • IndependenceIndependence not established

K253009

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 2026-09-08

No public price or quote for the exact K253009 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 K253009. 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 2026-09-08

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
2026-09-20Last searched
23Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. 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, acr ai central product, fda decision summary, 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 K253009: DS Core Detect

    U.S. Food and Drug Administration - Published 2026-01-07 - Accessed 2026-09-08

    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. DS Core Detect model card (K253009)

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

    Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, 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. openFDA exact recall query for K253009

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K253009 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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