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FDA 510(k)

VELMENI for DENTISTS (V4D) 3D

K-Number: K254096 · 2026-07-23

ApplicantVelmeni, Inc.
Decision Date2026-07-23
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VELMENI for DENTISTS (V4D) 3D is the device name listed in this FDA 510(k) record. The listed applicant is Velmeni, Inc.. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K254096. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VELMENI for DENTISTS (V4D) 3D?

VELMENI for DENTISTS (V4D) 3D is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Velmeni, Inc.. The 510(k) number is K254096.

When did VELMENI for DENTISTS (V4D) 3D receive FDA 510(k) clearance?

VELMENI for DENTISTS (V4D) 3D received FDA 510(k) clearance on 2026-07-23, under 510(k) number K254096.

Who is the listed applicant for VELMENI for DENTISTS (V4D) 3D?

The FDA 510(k) record lists Velmeni, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VELMENI for DENTISTS (V4D) 3D?

The FDA product code for VELMENI for DENTISTS (V4D) 3D is QIH.

Other records listing Velmeni, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252953Velmeni for Dentists (V4D) Endo-PerioK250753VELMENI for DENTISTS (V4D)K240003Velmeni for Dentists (V4D)

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261349SwiftMRAirs Medical, Inc.K260192DIANAROPCA ApSK261535Hi-D Imaging 4TAVRHi-D Imaging AGK260206SkeletonPlannerUPlanner B.V. - PresurgeoK260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.K253969ADAS 3DAdas3D Medical S.L.

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.

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