# K080438: Dental Unit with Chair

- Pathway: 510(k) (Traditional)
- Applicant: North West Medical Instrument (Group) Co., Ltd.
- Decided: Apr 4, 2008 after 45 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: 3 generations back to K962071 (1996). 3 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032543: Sirona Dental Systems C8+Dental Operative Unit with Accessories, Sirona Dental Systems GmbH (2003) Summary page 2.

## Most influential descendants
- K130410: Dental Unit with Chair (2013), 4 descendants of its own
- K142206: Dental Unit (2015), 3 descendants of its own
- K231845: Dental unit Model: Mare (2024), 2 descendants of its own
- K242611: Integral Dental Units (2025), 0 descendants of its own
- K242646: Dental Implant Unit (2025), 0 descendants of its own

## Indications for use
The Dental Unit with Chair 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/K080438
Methodology: https://510kreport.com/methodology