510(k) · Radiology

Velmeni for Dentists (V4D) Endo-Perio

by Velmeni, Inc.

Velmeni for Dentists (V4D) Endo-Perio is an AI-enabled medical device from Velmeni, Inc. that the U.S. FDA cleared through 510(k) K252953 on May 11, 2026. Its lead review panel is Radiology and its primary product code is MYN (Analyzer, Medical Image).

See also FDA-cleared AI radiology devices in 2026, all FDA AI clearances in 2026, top radiology AI devices.

Key facts

Submission numberK252953
Pathway510(k)
Date of final decision
Company (FDA list)Velmeni, Inc.
Lead review panelRadiology
Primary product codeMYN — Analyzer, Medical Image
Applicant (openFDA)Velmeni, Inc.
Applicant locationSunnyvale, CA, US
Device classClass 2
Regulation number21 CFR 892.2070
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Velmeni for Dentists (V4D) Endo-Perio went through this pathway (K252953).

openFDA lists it as a Class 2 device under 21 CFR 892.2070. Class II devices are moderate risk and are subject to general and special controls.

Product code MYN covers 43 devices on the FDA AI list. By decision date, this device is #43 of 43 under that code. Velmeni, Inc. has 3 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

Similar devices (product code MYN)

More from Velmeni, Inc.