# K200625: I-View Gold and Imagen Gold Dental Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Trident S.R.L
- Decided: Apr 15, 2020 after 36 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: 6 generations back to K933455 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153060: Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S, Rayence Co., Ltd. (2015) Summary page 4.

## Indications for use
I-View Gold sensors are digital dental intraoral sensors 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/K200625
Methodology: https://510kreport.com/methodology