# K251544: Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)

- Pathway: 510(k) (Traditional)
- Applicant: Lakong Medical Devices Co., Ltd.
- Decided: Aug 7, 2026 after 444 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
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 Dental Unit is intended to supply power to and serve as a base for dental devices; and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.

Source page: https://510kreport.com/device/K251544
Methodology: https://510kreport.com/methodology