FDA.report

510(k) K222746

Device
Overjet Caries Assist
Applicant
Overjet, Inc.
510(k) number
K222746
Product code
MYN
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-27
Date received
2022-09-12
Regulation
892.2070
Classification name
Analyzer, Medical Image
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Adam Odeh
Address
560 Harrison St., Unit 403 Boston MA US 02118 02118

FDA Registration Numbers

Source Documents

510(k) summary PDF

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