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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 K220928
Device Name Overjet Calculus Assist
Applicant
Overjet Inc.
560 Harrison Ave., Unit 403
Boston,  MA  02118
Applicant Contact Adam Odeh
Correspondent
Overjet Inc.
560 Harrison Ave., Unit 403
Boston,  MA  02118
Correspondent Contact Adam Odeh
Regulation Number892.2070
Classification Product Code
MYN  
Date Received03/31/2022
Decision Date 12/16/2022
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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