Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Analyzer, Medical Image
510(k) Number K261059
Device Name Overjet Multi-Image Caries and Charting Assist
Applicant
Overjet, Inc.
200 State St.
Suite 1220
Boston,  MA  02109
Applicant Contact Gayatri Sekaran
Correspondent
Overjet, Inc.
200 State St.
Suite 1220
Boston,  MA  02109
Correspondent Contact Alireza Sojoudi
Regulation Number892.2070
Classification Product Code
MYN  
Subsequent Product Code
QIH  
Date Received03/31/2026
Decision Date 08/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
-
-