Overjet Dental Assist

System, Image Processing, Radiological

Overjet, Inc.

The following data is part of a premarket notification filed by Overjet, Inc. with the FDA for Overjet Dental Assist.

Pre-market Notification Details

Device IDK210187
510k NumberK210187
Device Name:Overjet Dental Assist
ClassificationSystem, Image Processing, Radiological
Applicant Overjet, Inc. 560 Harrison Ave, Unit 403 Boston,  MA  02118
ContactAdam Heroux
CorrespondentAdam Heroux
Overjet, Inc. 560 Harrison Ave, Unit 403 Boston,  MA  02118
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-25
Decision Date2021-05-19

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.