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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K210187
Device Name Overjet Dental Assist
Applicant
Overjet, Inc.
560 Harrison Ave, Unit 403
Boston,  MA  02118
Applicant Contact Adam Heroux
Correspondent
Overjet, Inc.
560 Harrison Ave, Unit 403
Boston,  MA  02118
Correspondent Contact Adam Heroux
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/25/2021
Decision Date 05/19/2021
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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