# K243130: Integral Dental Unit

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Yadeng Medical Apparatus Co., Ltd.,
- Decided: Jun 27, 2025 after 270 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: 4 generations back to K962071 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183347: K3, Osstem Implant Co., Ltd. (2019) Summary page 5.

## Indications for use
The Integral Dental Unit is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

Source page: https://510kreport.com/device/K243130
Methodology: https://510kreport.com/methodology