Velmeni for Dentists (V4D)— 510(k) K240003

Substantially Equivalent

Velmeni, Inc.

FDA 510(k) clearance K240003 for Velmeni for Dentists (V4D), Substantially Equivalent on 2024-08-30. Applicant: Velmeni, Inc.. Device class: 2.

Clearance details

Applicant: Velmeni, Inc.
Product code: Code MYN
Device class: Class 2
Regulation: 21 CFR 892.2070
Advisory panel: Radiology
Date received: 2024-01-02
Decision date: 2024-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MYN

K252486 — ChestView US (1.1)2026-09-09
K261059 — Overjet Multi-Image Caries and Charting Assist2026-08-06
K260851 — Better Diagnostics Dental Assist (BDDA) Version 1.02026-07-15
K252953 — Velmeni for Dentists (V4D) Endo-Perio2026-05-11
K251934 — qXR-Detect2026-01-16

More clearances from Velmeni, Inc.

K254096 — VELMENI for DENTISTS (V4D) 3D2026-07-23
K250753 — VELMENI for DENTISTS (V4D)2025-09-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.