Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Overjet, Inc.. It received FDA 510(k) clearance on 2023-03-27 under 510(k) 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. The listed applicant is Overjet, Inc.. The 510(k) number is K222746.

When did Overjet Caries Assist receive FDA 510(k) clearance?

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

Who is the listed applicant for Overjet Caries Assist?

The FDA 510(k) record lists Overjet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Overjet Caries Assist?

The FDA product code for Overjet Caries Assist is MYN.

Other records listing Overjet, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261059Overjet Multi-Image Caries and Charting AssistK253930Overjet Iris Intelligent Imaging SystemK251514Overjet CBCT AssistK241681Overjet Image Enhancement AssistK241684Overjet Charting AssistK233738Overjet Caries Assist-Pediatric

View all 12 devices →

Related Devices (Code: MYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261059Overjet Multi-Image Caries and Charting AssistOverjet, Inc.K260851Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp.K252953Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc.K251934qXR-DetectQure.Ai TechnologiesK252934DiagnocatDGNCT, LLCK253009DS Core DetectDentsply Sirona, Inc.

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.

↑