# K213749: G7, Dental Operative Unit and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Shinhung Company, Ltd.
- Decided: Apr 3, 2023 after 489 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K102234 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151996: Taurus C1, Shinhung Company, Ltd. (2016) Summary page 5.

## Indications for use
The G7 Dental System and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.

Source page: https://510kreport.com/device/K213749
Methodology: https://510kreport.com/methodology