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FDA 510(k)

Denti.AI Detect

K-Number: K230144 · 2023-10-06

ApplicantDenti.Ai Technology, Inc.
Decision Date2023-10-06
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Denti.AI Detect is the device name listed in this FDA 510(k) record. The listed applicant is Denti.Ai Technology, Inc.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K230144. 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 Denti.AI Detect?

Denti.AI Detect is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Denti.Ai Technology, Inc.. The 510(k) number is K230144.

When did Denti.AI Detect receive FDA 510(k) clearance?

Denti.AI Detect received FDA 510(k) clearance on 2023-10-06, under 510(k) number K230144.

Who is the listed applicant for Denti.AI Detect?

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

What is the FDA product code for Denti.AI Detect?

The FDA product code for Denti.AI Detect is MYN.

Other records listing Denti.Ai Technology, 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.

K222054Denti.AI Auto-Chart

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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