# K102456: Intraoral Belsensor Gold

- Pathway: 510(k) (Traditional)
- Applicant: Takara Belmont USA, Inc.
- Decided: Dec 15, 2011 after 475 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). 7 ancestors in all.
1 later device descends from it; 1 cites 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)
- K090458: Dexis Sensor, Dexis, LLC (2009) Summary page 1.

## Most influential descendants
- K123419: Eva Select Digital Dental Imaging System (2012), 0 descendants of its own

## Indications for use
The BelSensor GOLD is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The BelSensor GOLD shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The BelSensor GOLD 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 a patient.

Source page: https://510kreport.com/device/K102456
Methodology: https://510kreport.com/methodology