Denti.AI Auto-Chart— 510(k) K222054

Substantially Equivalent

Denti.Ai Technology, Inc.

FDA 510(k) clearance K222054 for Denti.AI Auto-Chart, Substantially Equivalent on 2022-11-22. Applicant: Denti.Ai Technology, Inc..

Clearance details

Applicant: Denti.Ai Technology, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2022-07-12
Decision date: 2022-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.