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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
Overjet, Inc
560 Harrison Ave #403
Boston,  MA  02118
Applicant Contact Deepthi Paknikar
Overjet, Inc
560 Harrison Ave #403
Boston,  MA  02118
Correspondent Contact Deepthi Paknikar
Regulation Number892.2070
Classification Product Code
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