# K232440: Adravision Perio

- Pathway: 510(k) (Traditional)
- Applicant: Adra Corporation
- Decided: Dec 5, 2023 after 113 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 9 generations back to K930527 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210187: Overjet Dental Assist, Overjet, Inc. (2021) Summary page 5.

## Indications for use
Adravision Perio 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 intended users of Adravision Perio are trained professionals including, but not limited to, dentists and dental hygienists. 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. Adra Corporation has not evaluated the performance of the device on primary dentition.

Source page: https://510kreport.com/device/K232440
Methodology: https://510kreport.com/methodology