# K254009: Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)

- Pathway: 510(k) (Traditional)
- Applicant: Lakong Medical Devices Co., Ltd.
- Decided: Sep 10, 2026 after 269 days
- Product code: SJH (Portable Dental Operative Unit)
- 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
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
The Portable Dental Unit is intended to supply power and serve as a base for dental devices and accessories. This device delivers air, water, vacuum, and electricity to handheld instruments, for use in dental clinics and hospitals. It is designed to be used by professional dental practitioners.

Source page: https://510kreport.com/device/K254009
Methodology: https://510kreport.com/methodology