Overjet Caries Assist
K-Number: K212519 · 2022-05-10
ApplicantOverjet, Inc.
Decision Date2022-05-10
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Overjet Caries Assist is a medical device manufactured by Overjet, Inc.. It received FDA 510(k) clearance on 2022-05-10 under approval number K212519. 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 Caries Assist?
Overjet Caries Assist is a medical device that received FDA 510(k) clearance on 2022-05-10. It is manufactured by Overjet, Inc.. The 510(k) number is K212519.
When was Overjet Caries Assist approved by the FDA?
Overjet Caries Assist received FDA 510(k) clearance on 2022-05-10, under approval number K212519.
What company makes Overjet Caries Assist?
Overjet Caries Assist is manufactured by Overjet, Inc..
What is the FDA product code for Overjet Caries Assist?
The FDA product code for Overjet Caries 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.