Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Overjet Caries Assist

K-Number: K222746 · 2023-03-27

ApplicantOverjet, Inc.
Decision Date2023-03-27
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 2023-03-27 under approval number K222746. 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 2023-03-27. It is manufactured by Overjet, Inc.. The 510(k) number is K222746.

When was Overjet Caries Assist approved by the FDA?

Overjet Caries Assist received FDA 510(k) clearance on 2023-03-27, under approval number K222746.

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.

View all 11 devices →

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.