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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 K230144
Device Name Denti.AI Detect
Applicant
Denti.AI Technology, Inc.
99 Yorkville Ave, Suite 214
Toronto,  CA M5R3k5
Applicant Contact Lyudmila Tuzova
Correspondent
Biologics Consulting
100 Daingerfield Road
Suite 400
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number892.2070
Classification Product Code
MYN  
Subsequent Product Code
LLZ  
Date Received01/18/2023
Decision Date 10/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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