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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K251514
Device Name Overjet CBCT Assist
Applicant
Overjet, Inc.
200 State St. Suite 1220
Boston,  MA  02109
Applicant Contact Alireza Sojoudi
Correspondent
Overjet, Inc.
200 State St. Suite 1220
Boston,  MA  02109
Correspondent Contact Alireza Sojoudi
Regulation Number892.2050
Classification Product Code
QIH  
Date Received05/16/2025
Decision Date 12/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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