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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 a medical device manufactured by Denti.Ai Technology, Inc.. It received FDA 510(k) clearance on 2023-10-06 under approval 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. It is manufactured by Denti.Ai Technology, Inc.. The 510(k) number is K230144.

When was Denti.AI Detect approved by the FDA?

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

What company makes Denti.AI Detect?

Denti.AI Detect is manufactured by Denti.Ai Technology, Inc..

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

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

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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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