Cleared Traditional

K230144 - Denti.AI Detect

K230144 is an FDA 510(k) clearance for Denti.AI Detect, manufactured by Denti.Ai Technology, Inc.. The device is a Class 2 Radiology device with product code MYN cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K230144 · Denti.Ai Technology, Inc. · Radiology device
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Oct 2023
Decision
261d
Days
Class 2
Risk

K230144 is an FDA 510(k) clearance for the Denti.AI Detect. Classified as Analyzer, Medical Image (product code MYN), Class II - Special Controls.

Submitted by Denti.Ai Technology, Inc. (Toronto, CA). The FDA issued a Cleared decision on October 6, 2023 after a review of 261 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2070 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Denti.Ai Technology, Inc. devices

FDA 510(k) Submission Details - K230144

510(k) Number K230144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2023
Decision Date October 06, 2023
Days to Decision 261 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 107d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYN Device Classification - Class 2, Special Controls

Product Code MYN Analyzer, Medical Image
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2070
Definition For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Biologics Consulting
Donna-Bea Tillman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MYN Analyzer, Medical Image

All 36
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