# K972921: Sanko Intraoral Dental X-Ray

- Pathway: 510(k) (Traditional)
- Applicant: Sanko X-Ray Manufacturing Co., Ltd.
- Decided: Jan 6, 1998 after 151 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Intraoral dental x-ray machine, wall mounted system that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Source page: https://510kreport.com/device/K972921
Methodology: https://510kreport.com/methodology