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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Medical Image
510(k) Number K252953
Device Name Velmeni for Dentists (V4D) Endo-Perio
Applicant
Velmeni, Inc.
333 W. Maude Ave.
Sunnyvale,  CA  94085
Applicant Contact Mini Suri
Correspondent
Velmeni, Inc.
333 W. Maude Ave.
STE 207
Sunnyvale,  CA  94085
Correspondent Contact Mini Suri
Regulation Number892.2070
Classification Product Code
MYN  
Date Received09/16/2025
Decision Date 05/11/2026
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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