# K214091: Dental Image Plate Scanner, Model DFC-4T-SMART

- Pathway: 510(k) (Traditional)
- Applicant: Hefei Dentafilm Medical Equipment Co., Ltd.
- Decided: Mar 2, 2022 after 64 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: 1 generation back to K192766 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192766: Digital Intraoral Imaging Plate System, Fsusen Technology Co., Ltd. (2019) Summary page 5.

## Indications for use
The Dental Image Plate Scanner, Model DFC-4T-SMART is intended to be used to scan dental X-ray latent images contained in the intraoral imaging plate and then generate, browse, process and review the intraoral dental digital X-ray image.

Source page: https://510kreport.com/device/K214091
Methodology: https://510kreport.com/methodology