# K153060: Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S

- Pathway: 510(k) (Special)
- Applicant: Rayence Co., Ltd.
- Decided: Nov 10, 2015 after 20 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). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150797: Digital Dental Intra Oral Sensor, EzSensor Smart, Rayence Co., Ltd. (2015) Summary page 5.

## Most influential descendants
- K230916: WeSensor (2023), 0 descendants of its own
- K200625: I-View Gold and Imagen Gold Dental Sensors (2020), 0 descendants of its own

## Indications for use
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/K153060
Methodology: https://510kreport.com/methodology