Velmeni for Dentists (V4D)

FDA 510(k) K240003 · Velmeni, Inc.

Substantially Equivalent

510(k) numberK240003

Submission

Device name
Velmeni for Dentists (V4D)
Applicant
Velmeni, Inc.
Sunnyvale, CA, US
Received
January 2, 2024
Decision date
August 30, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MYN – Analyzer, Medical Image
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2070
Specialty
Radiology

For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers

Other 510(k)s with product code MYN

510(k)DeviceApplicantDecision
K252486ChestView US (1.1)MYN · Traditional Gleamer09/09/2026SE
K261059Overjet Multi-Image Caries and Charting AssistMYN · Traditional Overjet, Inc.08/06/2026SE
K260851Better Diagnostics Dental Assist (BDDA) Version 1.0MYN · Traditional Better Diagnostics AI Corp.07/15/2026SE
K252953Velmeni for Dentists (V4D) Endo-PerioMYN · Traditional Velmeni, Inc.05/11/2026SE
K251934qXR-DetectMYN · Traditional Qure.Ai Technologies01/16/2026SE
K252934DiagnocatMYN · Traditional Dgnct, LLC01/15/2026SE
K253009DS Core DetectMYN · Traditional Dentsply Sirona, Inc.01/07/2026SE
K252086DTX Studio AssistMYN · Traditional Nobel Biocare C/O Medicim NV11/17/2025SE
K250525Second Opinion® PanoramicMYN · Traditional Pearl, Inc.11/14/2025SE
K250264SugarBug (1.x)MYN · Traditional Bench7, Inc.11/07/2025SE

More from Bench7, Inc.

510(k)DeviceDecision
K254096VELMENI for DENTISTS (V4D) 3DQIH · Traditional 07/23/2026SE
K252953Velmeni for Dentists (V4D) Endo-PerioMYN · Traditional 05/11/2026SE
K250753VELMENI for DENTISTS (V4D)MYN · Traditional 09/02/2025SE

Questions and answers

When was Velmeni for Dentists (V4D) cleared by the FDA?

Velmeni for Dentists (V4D) (K240003) received a 510(k) decision of Substantially Equivalent on August 30, 2024, 241 days after the submission was received.

What is the product code of K240003?

The FDA product code is MYN – Analyzer, Medical Image, a Class II (moderate risk) device regulated under 21 CFR 892.2070.