Velmeni for Dentists (V4D) Endo-Perio— 510(k) K252953

Name: FDA 510(k) clearance K252953
Creator: U.S. Food and Drug Administration
Published: 2026-05-11

Substantially Equivalent

Velmeni, Inc.

FDA 510(k) clearance K252953 for Velmeni for Dentists (V4D) Endo-Perio, Substantially Equivalent on 2026-05-11. Applicant: Velmeni, Inc.. Device class: 2.

Summary

Velmeni's Velmeni for Dentists (V4D) Endo-Perio is filed under MYN, medical image analyzers.

Class II, 21 CFR 892.2070. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).

Velmeni filed from Sunnyvale, California. Review took 237 calendar days (September 16, 2025 to May 11, 2026).

Clearance details

Applicant: Velmeni, Inc.
Product code: Product code MYN
Device class: Class 2
Regulation: 21 CFR 892.2070
Advisory panel: Radiology
Date received: 2025-09-16
Decision date: 2026-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Velmeni, Inc.

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K254096 — VELMENI for DENTISTS (V4D) 3D2026-07-23
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.