VELMENI for DENTISTS (V4D)

K250753

Velmeni Inc. · cleared 2025-09-02 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“VELMENI for DENTISTS (V4D) is a concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings/restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years of age or older.”
AlgorithmMachine Learning (ML) Engine delivers V4D's core ML capabilities through the radiograph type classifier, condition detection module, tooth numbering module, and merging module.
source quote (p.5)
“Machine Learning (ML) Engine delivers V4D's core ML capabilities through the radiograph type classifier, condition detection module, tooth numbering module, and merging module.”
Adaptive (vs locked)Yes
source quote (p.6)
“The PCCPs include key components (data management, retraining, performance evaluation, update procedures, and impact assessments) that describe the plan for developing, validating, and implementing the modifications using post-market and real-world data to reduce false positives and negatives.”
PCCPYes
source quote (p.2)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedYes
source quote (p.9)
“Velmeni maintains adherence to FDA guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, throughout the course of model modifications under the authorized PCCP.”

Validation studies (0)

FDA source did not describe a validation study.

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
-100%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K250753