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)

Videa Dental Assist

K-Number: K232384 · 2023-12-15

ApplicantVideahealth, Inc.
Decision Date2023-12-15
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Videa Dental 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 2023-12-15 under 510(k) number K232384. 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 Dental Assist?

Videa Dental Assist is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Videahealth, Inc.. The 510(k) number is K232384.

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

Videa Dental Assist received FDA 510(k) clearance on 2023-12-15, under 510(k) number K232384.

Who is the listed applicant for Videa Dental 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 Dental Assist?

The FDA product code for Videa Dental 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 AIK223296Videa Perio AssistK213795Videa Caries 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

View on FDA Database →

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

↑