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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Overjet, Inc.. It received FDA 510(k) clearance on 2022-12-16 under 510(k) 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. The listed applicant is Overjet, Inc.. The 510(k) number is K220928.

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

Overjet Calculus Assist received FDA 510(k) clearance on 2022-12-16, under 510(k) number K220928.

Who is the listed applicant for Overjet Calculus 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 Calculus Assist?

The FDA product code for Overjet Calculus 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.

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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.

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.

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