# K231678: Overjet Periapical Radiolucency Assist

- Pathway: 510(k) (Traditional)
- Applicant: Overjet, Inc.
- Decided: Sep 21, 2023 after 104 days
- Product code: MYN (Analyzer, Medical Image)
- Device class: 2
- Regulation: 21 CFR 892.2070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P980025 (1998). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221921: DTX Studio Clinic 3.0, Nobel Biocare AB (2023) Summary page 4.
- K210365: Second Opinion, Pearl, Inc. (2022) Summary page 4.

## Most influential descendants
- K252934: Diagnocat (2026), 0 descendants of its own
- K242600: Second Opinion Periapical Radiolucency Contours (2025), 0 descendants of its own

## Indications for use
Overjet Periapical Radiolucency (PARL) Assist is a radiological, automated, concurrent read computer-assisted detection software intended to aid in the detection of periapical radiolucencies on permanent teeth captured on periapical radiographs. The device provides additional aid for the dentist to use in their identification of periapical radiolucency. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment that considers other relevant information from the image or patient history. The system is to be used by professionally trained and licensed dentists. The Overjet Periapical Radiolucency Assist software is indicated for use on patients 12 years of age or older.

Source page: https://510kreport.com/device/K231678
Methodology: https://510kreport.com/methodology