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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 K212519
Device Name Overjet Caries Assist
Applicant
Overjet, Inc.
560 Harrison Ave, Unit 403
Boston,  MA  02118
Applicant Contact Wardah Inam
Correspondent
Overjet, Inc.
560 Harrison Ave, Unit 403
Boston,  MA  02118
Correspondent Contact Adam Odeh
Regulation Number892.2070
Classification Product Code
MYN  
Date Received08/10/2021
Decision Date 05/10/2022
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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