Denti.AI Auto-Chart

FDA 510(k) K222054 · Denti.Ai Technology, Inc.

Substantially Equivalent

510(k) numberK222054

Submission

Device name
Denti.AI Auto-Chart
Applicant
Denti.Ai Technology, Inc.
Toronto, CA
Received
July 12, 2022
Decision date
November 22, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Denti.AI Auto-Chart cleared by the FDA?

Denti.AI Auto-Chart (K222054) received a 510(k) decision of Substantially Equivalent on November 22, 2022, 133 days after the submission was received.

What is the product code of K222054?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.