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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K254096
Device Name VELMENI for DENTISTS (V4D) 3D
Applicant
Velmeni, Inc.
333 W. Maude Ave.
Sunnyvale,  CA  94085
Applicant Contact Mini Suri
Correspondent
Velmeni, Inc.
333 W. Maude Ave.
Sunnyvale,  CA  94085
Correspondent Contact Mini Suri
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/19/2025
Decision Date 07/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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