Overjet Calculus Assist
K-Number: K220928 · 2022-12-16
ApplicantOverjet, Inc.
Decision Date2022-12-16
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Overjet Calculus Assist is a medical device manufactured by Overjet, Inc.. It received FDA 510(k) clearance on 2022-12-16 under approval number K220928. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Overjet Calculus Assist?
Overjet Calculus Assist is a medical device that received FDA 510(k) clearance on 2022-12-16. It is manufactured by Overjet, Inc.. The 510(k) number is K220928.
When was Overjet Calculus Assist approved by the FDA?
Overjet Calculus Assist received FDA 510(k) clearance on 2022-12-16, under approval number K220928.
What company makes Overjet Calculus Assist?
Overjet Calculus Assist is manufactured by Overjet, Inc..
What is the FDA product code for Overjet Calculus Assist?
The FDA product code for Overjet Calculus Assist is MYN.
Other Devices by Overjet, Inc.
Related Devices (Code: MYN)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.