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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 K231678
Device Name Overjet Periapical Radiolucency Assist
Applicant
Overjet, Inc
560 Harrison Ave #403
Boston,  MA  02118
Applicant Contact Deepthi Paknikar
Correspondent
Overjet, Inc
560 Harrison Ave #403
Boston,  MA  02118
Correspondent Contact Deepthi Paknikar
Regulation Number892.2070
Classification Product Code
MYN  
Date Received06/09/2023
Decision Date 09/21/2023
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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