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FDA 510(k)

Velmeni for Dentists (V4D) Endo-Perio

K-Number: K252953 · 2026-05-11

ApplicantVelmeni, Inc.
Decision Date2026-05-11
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Velmeni for Dentists (V4D) Endo-Perio is a medical device manufactured by Velmeni, Inc.. It received FDA 510(k) clearance on 2026-05-11 under approval number K252953. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Velmeni for Dentists (V4D) Endo-Perio?

Velmeni for Dentists (V4D) Endo-Perio is a medical device that received FDA 510(k) clearance on 2026-05-11. It is manufactured by Velmeni, Inc.. The 510(k) number is K252953.

When was Velmeni for Dentists (V4D) Endo-Perio approved by the FDA?

Velmeni for Dentists (V4D) Endo-Perio received FDA 510(k) clearance on 2026-05-11, under approval number K252953.

What company makes Velmeni for Dentists (V4D) Endo-Perio?

Velmeni for Dentists (V4D) Endo-Perio is manufactured by Velmeni, Inc..

What is the FDA product code for Velmeni for Dentists (V4D) Endo-Perio?

The FDA product code for Velmeni for Dentists (V4D) Endo-Perio is MYN.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.