# K222054: Denti.AI Auto-Chart

- Pathway: 510(k) (Traditional)
- Applicant: Denti.Ai Technology, Inc.
- Decided: Nov 22, 2022 after 133 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K930527 (1993). 12 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220003: EzOrtho v1.3, Ewoosoft Co., Ltd. (2022) Summary page 4.

## Most influential descendants
- K233590: Overjet Charting Assist (2024), 2 descendants of its own
- K241684: Overjet Charting Assist (2024), 1 descendant of its own
- K261059: Overjet Multi-Image Caries and Charting Assist (2026), 0 descendants of its own

## Indications for use
Denti.AI Auto-Chart is a Medical Image Management and Processing System (MIMPS) device aimed to assist dental professionals (Users), comprising general dentists, dental specialists, and dental hygienists, in detecting dental structures and producing dental charting data based on the interpretation of intraoral and extraoral 2D X-Ray images. Denti.AI Auto-Chart is intended to assist in: • Detecting natural dental structures: teeth and missing teeth • Detecting dental structures added through past restorative treatment: implants, crowns, pontics, endodontic treatment, fillings • Choosing treatment options • Producing dental charts based on image analysis results as well as conditions added manually or produced by integrated CAD devices The device is aimed to be used with images from the adult population only (≥22 years old and do not have remaining primary teeth). The device is not intended as a replacement for a complete clinician's review or clinical judgment that considers other relevant information from the image or patient history.

Source page: https://510kreport.com/device/K222054
Methodology: https://510kreport.com/methodology