# K143753: Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio

- Pathway: 510(k) (Special)
- Applicant: Rayence Co., Ltd.
- Decided: Mar 10, 2015 after 69 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: 4 generations back to K933455 (1994). 5 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090526: Medical Image Processing Unit, Model Ezsensor, E-Woo Technology (2009) Summary page 5.

## Most influential descendants
- K151707: EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i (2015), 5 descendants of its own
- K232255: EZSensor XHD (2023), 3 descendants of its own
- K242778: X Sensor (Model:  IOS-A15IF, HDI-15DGF) (2024), 2 descendants of its own
- K252570: EzSensor HD, EzSensor UHD (2025), 1 descendant of its own
- K261663: EzSensor HD (2026), 0 descendants of its own

## Indications for use
EzSensor Soft [Alternative name : EzSensor Bio] Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

Source page: https://510kreport.com/device/K143753
Methodology: https://510kreport.com/methodology