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FDA 510(k)

Overjet Multi-Image Caries and Charting Assist

K-Number: K261059 · 2026-08-06

ApplicantOverjet, Inc.
Decision Date2026-08-06
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Overjet Multi-Image Caries and Charting 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 2026-08-06 under 510(k) number K261059. 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 Multi-Image Caries and Charting Assist?

Overjet Multi-Image Caries and Charting Assist is a medical device that received FDA 510(k) clearance on 2026-08-06. The listed applicant is Overjet, Inc.. The 510(k) number is K261059.

When did Overjet Multi-Image Caries and Charting Assist receive FDA 510(k) clearance?

Overjet Multi-Image Caries and Charting Assist received FDA 510(k) clearance on 2026-08-06, under 510(k) number K261059.

Who is the listed applicant for Overjet Multi-Image Caries and Charting 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 Multi-Image Caries and Charting Assist?

The FDA product code for Overjet Multi-Image Caries and Charting 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.

K253930Overjet Iris Intelligent Imaging SystemK251514Overjet CBCT AssistK241681Overjet Image Enhancement AssistK241684Overjet Charting AssistK233738Overjet Caries Assist-PediatricK233590Overjet Charting Assist

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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.

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.K252086DTX Studio AssistNobel Biocare C/O Medicim NV

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.

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