510(k) Report

FDA applicant

Denti.Ai Technology, Inc.

Toronto, CA2 decisions2022–20230 recalls

FDA records 2 decisions for Denti.Ai Technology, Inc. (Toronto, CA) from 2022 to 2023: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and MYN (Analyzer, Medical Image). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Denti.Ai Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022: 12023: 1
2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Denti.Ai Technology, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision
  • MYNAnalyzer, Medical Image1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K222054Denti.AI Auto-ChartDenti.Ai Technology, Inc. · 20221cites it
  • K230144Denti.AI DetectDenti.Ai Technology, Inc. · 20231cites it

What has FDA decided for it lately?

  • K230144Denti.AI DetectDenti.Ai Technology, Inc. · 2023
  • K222054Denti.AI Auto-ChartDenti.Ai Technology, Inc. · 2022

All 2 as Denti.Ai Technology, Inc. →