Authorized purpose: Concurrent-read CADe to assist dentists in detecting specified tooth and jaw anatomy, bone-level landmarks, and root-canal-treated teeth in digital radiographs of permanent teeth in patients 15 years or older.
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 CADe to assist dentists in detecting specified tooth and jaw anatomy, bone-level landmarks, and root-canal-treated teeth in digital radiographs of permanent teeth in patients 15 years or older.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Concurrent-read CADe to assist dentists in detecting specified tooth and jaw anatomy, bone-level landmarks, and root-canal-treated teeth in digital radiographs of permanent teeth in patients 15 years or older.
Which images or clinical context are in scope?Modality: X-ray/Radiography Anatomy or clinical context: Permanent teeth and jaw/maxillofacial anatomy, including enamel, dentine, pulp, root, mental foramen, inferior alveolar canal, maxillary sinus, cementoenamel junction, crestal bone, and root-canal-treated teeth Input: Grayscale digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years or older; the device description identifies JPEG and PNG supported extensions.
Who uses it?Intended users: Dentists
What does the software produce?Output: Detection and segmentation of tooth anatomy, jaw anatomy, bone-level landmarks, and root-canal-treated teeth; users may edit model segmentations and bone-level landmarks through the web application.
What is its most important limitation?Key limitation: Not a replacement for a complete dentist examination or clinical judgment using the image, patient history, and in-vivo assessment. Final diagnoses and treatment plans are the dentist's responsibility; scope is permanent teeth in patients 15 years or older.
Clinical takeaway
Clinical role: Concurrent-read CADe to assist dentists in detecting specified tooth and jaw anatomy, bone-level landmarks, and root-canal-treated teeth in digital radiographs of permanent teeth in patients 15 years or older.
Evidence takeaway
Evidence from the reviewed source record: FDA software verification/validation passed. Standalone testing used bitewing data from 128 patients/272 images/1,791 teeth, periapical data from 137 patients/271 images/1,213 teeth, panoramic data from 245 patients/248 images/496 sides, and 137 root-canal images; ground truth used three US-licensed dentists plus a US-licensed dental radiologist adjudicator. Tooth sensitivity in the reported primary tables ranged from 94.4% to 100.0% for bitewing and 96.2% to 99.8% for periapical anatomy; jaw-feature sensitivity was 99.8% for mandibular canal, 81.5% for mental foramen, and 99.8% for maxillary sinus. Bone-level absolute-error means were 0.25/0.27 mm for bitewing distal/mesial and 0.44/0.47 mm for periapical distal/mesial measures.
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 CADe to assist dentists in detecting specified tooth and jaw anatomy, bone-level landmarks, and root-canal-treated teeth in digital radiographs of permanent teeth in patients 15 years or older.
Grayscale digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years or older; the device description identifies JPEG and PNG supported extensions.
Detection and segmentation of tooth anatomy, jaw anatomy, bone-level landmarks, and root-canal-treated teeth; users may edit model segmentations and bone-level landmarks through the web application.
Not a replacement for a complete dentist examination or clinical judgment using the image, patient history, and in-vivo assessment. Final diagnoses and treatment plans are the dentist's responsibility; scope is permanent teeth in patients 15 years or older.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
Web application with backend API, queue/AI worker, database and file storage, plus VELMENI Bridge for exchange with patient-management or imaging software. The FDA packet does not establish a specific PACS, RIS, or EHR standard.
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 Velmeni for Dentists (V4D) Endo-Perio; FDA labeling remains controlling for clinical use, limitations, and performance.
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 software verification/validation passed. Standalone testing used bitewing data from 128 patients/272 images/1,791 teeth, periapical data from 137 patients/271 images/1,213 teeth, panoramic data from 245 patients/248 images/496 sides, and 137 root-canal images; ground truth used three US-licensed dentists plus a US-licensed dental radiologist adjudicator. Tooth sensitivity in the reported primary tables ranged from 94.4% to 100.0% for bitewing and 96.2% to 99.8% for periapical anatomy; jaw-feature sensitivity was 99.8% for mandibular canal, 81.5% for mental foramen, and 99.8% for maxillary sinus. Bone-level absolute-error means were 0.25/0.27 mm for bitewing distal/mesial and 0.44/0.47 mm for periapical distal/mesial measures.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Velmeni for Dentists (V4D) Endo-Perio regulatory performance study summary
DesignStand-Alone Performance
PopulationAdult
Scopeexact submission
Tested versionExact product version not reported; regulatory study summarized for FDA submission K252953
IndependenceIndependence not established
K252953
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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 K252953 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 K252953. 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.
Verify deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
Verify pricing and total cost: No public price or quote for the exact K252953 configuration was established in this review.
Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
21Fields 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 history7 sources - 3 history items
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