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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 K260851
Device Name Better Diagnostics Dental Assist (BDDA) Version 1.0
Applicant
Better Diagnostics AI Corp.
29 Alcott Way
Avon,  CT  06001
Applicant Contact Rajeev Nohria
Correspondent
LucidMind Consulting
B202, Park Ave., Mg Rd.
Kandivli W.
Mumbai,  IN 400067
Correspondent Contact Raj Zaveri
Regulation Number892.2070
Classification Product Code
MYN  
Date Received03/16/2026
Decision Date 07/15/2026
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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