VELMENI for DENTISTS (V4D) 3D— 510(k) K254096

Substantially Equivalent

Velmeni, Inc.

FDA 510(k) clearance K254096 for VELMENI for DENTISTS (V4D) 3D, Substantially Equivalent on 2026-07-23. Applicant: Velmeni, Inc.. Device class: 2.

Clearance details

Applicant: Velmeni, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-12-19
Decision date: 2026-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

More clearances from Velmeni, Inc.

K252953 — Velmeni for Dentists (V4D) Endo-Perio2026-05-11
K250753 — VELMENI for DENTISTS (V4D)2025-09-02
K240003 — Velmeni for Dentists (V4D)2024-08-30

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