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FDA 510(k)

Videa Caries Assist

K-Number: K213795 · 2022-04-21

ApplicantVideahealth, Inc.
Decision Date2022-04-21
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Videa Caries Assist is the device name listed in this FDA 510(k) record. The listed applicant is Videahealth, Inc.. It received FDA 510(k) clearance on 2022-04-21 under 510(k) number K213795. 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 Videa Caries Assist?

Videa Caries Assist is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Videahealth, Inc.. The 510(k) number is K213795.

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

Videa Caries Assist received FDA 510(k) clearance on 2022-04-21, under 510(k) number K213795.

Who is the listed applicant for Videa Caries Assist?

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

What is the FDA product code for Videa Caries Assist?

The FDA product code for Videa Caries Assist is MYN.

Other records listing Videahealth, 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.

K251002Videa Dental AIK232384Videa Dental AssistK223296Videa Perio Assist

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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