# K242611: Integral Dental Units

- Pathway: 510(k) (Traditional)
- Applicant: Mipont Medical Equipment Co., Ltd.
- Decided: May 27, 2025 after 266 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: 7 generations back to K962071 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231845: Dental unit Model: Mare, Foshan Safety Medical Equipment Co., Ltd. (2024) Summary page 6.
- K233921: Luvis Chair (LC700C), Dentis Co., Ltd. (2024). Cleared while this submission was under review Summary page 6.

## 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/K242611
Methodology: https://510kreport.com/methodology