# K250753: VELMENI for DENTISTS (V4D)

- Pathway: 510(k) (Traditional)
- Applicant: Velmeni, Inc.
- Decided: Sep 2, 2025 after 174 days
- Product code: MYN (Analyzer, Medical Image)
- Device class: 2
- Regulation: 21 CFR 892.2070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to P980025 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240003: Velmeni for Dentists (V4D), Velmeni, Inc. (2024) Summary page 6.

## Indications for use
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. This device provides additional information for dentists in examining radiographs of patients’ teeth. This device is not intended as a replacement for a complete examination by the dentist or their clinical judgment that considers other relevant information from the image, patient history, or actual in vivo clinical assessment. Final diagnoses and patient treatment plans are the responsibility of the dentist. This device includes a Predetermined Change Control Plan (PCCP).

Source page: https://510kreport.com/device/K250753
Methodology: https://510kreport.com/methodology