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FDA 510(k)

VELMENI for DENTISTS (V4D)

K-Number: K250753 · 2025-09-02

ApplicantVelmeni, Inc.
Decision Date2025-09-02
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VELMENI for DENTISTS (V4D) is a medical device manufactured by Velmeni, Inc.. It received FDA 510(k) clearance on 2025-09-02 under approval number K250753. 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)?

VELMENI for DENTISTS (V4D) is a medical device that received FDA 510(k) clearance on 2025-09-02. It is manufactured by Velmeni, Inc.. The 510(k) number is K250753.

When was VELMENI for DENTISTS (V4D) approved by the FDA?

VELMENI for DENTISTS (V4D) received FDA 510(k) clearance on 2025-09-02, under approval number K250753.

What company makes VELMENI for DENTISTS (V4D)?

VELMENI for DENTISTS (V4D) is manufactured by Velmeni, Inc..

What is the FDA product code for VELMENI for DENTISTS (V4D)?

The FDA product code for VELMENI for DENTISTS (V4D) is MYN.

Other Devices by Velmeni, Inc.

K240003Velmeni for Dentists (V4D) K252953Velmeni for Dentists (V4D) Endo-Perio

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Official Source

View on FDA Database →

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

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