# K172918: DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)

- Pathway: 510(k) (Traditional)
- Applicant: Kavo Dental Technologies, LLC
- Decided: Dec 18, 2017 after 84 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933455 (1994). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090458: Dexis Sensor, Dexis, LLC (2009) Summary page 4.

## Most influential descendants
- K233053: DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor (2023), 0 descendants of its own
- K203116: SensorX (2021), 0 descendants of its own

## Recalls of this device
- Apr 29, 2019 · Class II · Z-1387-2019: The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.

## Indications for use
The DEXIS / KaVo sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo 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/K172918
Methodology: https://510kreport.com/methodology