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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 K233738
Device Name Overjet Caries Assist-Pediatric
Applicant
Overjet, Inc
50 Milk Street, 16th Floor
Boston,  MA  02109
Applicant Contact Deepthi Paknikar
Correspondent
Overjet, Inc
50 Milk Street, 16th Floor
Boston,  MA  02109
Correspondent Contact Deepthi Paknikar
Regulation Number892.2070
Classification Product Code
MYN  
Date Received11/22/2023
Decision Date 03/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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