# K233053: DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Dental Imaging Technologies Corporation
- Decided: Nov 21, 2023 after 57 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933455 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172918: DEXIS Titanium, KaVo IXS HD (Size 1, Size 2), Kavo Dental Technologies, LLC (2017) Summary page 4.

## Indications for use
The DEXIS sensor is a USB- driven digital sensor which is intended to acquire dental intra- oral radiographic images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra- oral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.

Source page: https://510kreport.com/device/K233053
Methodology: https://510kreport.com/methodology