# K210187: Overjet Dental Assist

- Pathway: 510(k) (Traditional)
- Applicant: Overjet, Inc.
- Decided: May 19, 2021 after 114 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: 8 generations back to K930527 (1993). 9 ancestors in all.
6 later devices descend from it; 5 cite 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)
- K192888: EzOrtho, Ewoosoft Co., Ltd. (2020) Summary page 5.

## Most influential descendants
- K230144: Denti.AI Detect (2023), 1 descendant of its own
- K260851: Better Diagnostics Dental Assist (BDDA) Version 1.0 (2026), 0 descendants of its own
- K250525: Second Opinion® Panoramic (2025), 0 descendants of its own
- K243230: Second Opinion® BLE (2025), 0 descendants of its own
- K232440: Adravision Perio (2023), 0 descendants of its own

## Indications for use
Overjet Dental Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, dentists and dental hygienists. Intended Patient Population: The intended patient population of the device is patients living in the United States, who are 22 years old or older, and that do not have any remaining primary teeth. Overjet has not evaluated the performance of the device on primary dentition.

Source page: https://510kreport.com/device/K210187
Methodology: https://510kreport.com/methodology