FDA-cleared profile
Velmeni Inc.
Authorized purpose: Assists dentists in detecting caries, fillings/restorations, fixed prostheses, and implants on digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients aged 15 years and older; final diagnoses and treatment plans remain the dentist's responsibility.
Product overview
Authorized purpose: Assists dentists in detecting caries, fillings/restorations, fixed prostheses, and implants on digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients aged 15 years and older; final diagnoses and treatment plans remain the dentist's responsibility.
Overview status: Source-reviewed overview
Clinical role: Assists dentists in detecting caries, fillings/restorations, fixed prostheses, and implants on digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients aged 15 years and older; final diagnoses and treatment plans remain the dentist's responsibility.
Evidence from the reviewed source record: The proposed device remains unchanged from the predicate Velmeni for Dentists cleared under K240003, hence, no additional software testing was conducted. The intended use of both the predicate device and the proposed device is identical. The existing data from the previous testing remains applicable.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
Conservative normalization of explicit wording in an exact-submission source.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The exact device description supports the ML capabilities and returned analysis results, but it does not state the current overlay/localization wording.
The exact indications for use provide the clinician-review and final-responsibility boundary; commercial deployment and pricing are not stated in the packet.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
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, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
The official 2D product page identifies panoramic, bitewing, and periapical X-rays as supported inputs and describes near-real-time analysis in seconds.
product family · checked 2026-09-06Exact K250753 release output, latency measurement, and interface requirements require confirmation.
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.
The exact performance section states the software-testing and existing-data boundary for the proposed device.
This field has not been curated yet.
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
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.
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
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
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
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, fda decision summary packet, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, modality, anatomy, intendedUsers, input, output, limitations, evidenceSummary, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: purpose, modality, intendedUsers, careSetting, output, anatomy
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: identity, clinical, evidence, implementation
Scope: buyer_workflow, clinical, implementation
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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