# K220928: Overjet Calculus Assist

- Pathway: 510(k) (Traditional)
- Applicant: Overjet, Inc.
- Decided: Dec 16, 2022 after 260 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: 1 generation back to P980025 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P980025: Logicon Caries Detector, Carestream Dental, LLC (1998) Summary page 5.

## Indications for use
Overjet Calculus Assist (OCalA) is a radiological automated concurrent-read computer-assisted detection software intended to aid in the detection of interproximal calculus deposits on both bitewing and periapical radiographs. The Overjet Calculus Assist surrounds suspected calculus deposits with a bounding box. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of containing calculus deposits. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment that takes into account other relevant information from the image or patient history. The system is to be used by professionally trained and licensed dentists.

Source page: https://510kreport.com/device/K220928
Methodology: https://510kreport.com/methodology