# K043496: Spaceline Emcia, Model CU580

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Feb 16, 2005 after 61 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: 2 generations back to K962071 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983242: Sirona C8 Dental Operative Unit with Accessories, Sirona Dental Systems GmbH (1998) Summary page 1.
- K953865: Spaceline Feel 21, J. Morita USA, Inc. (1996) Summary page 2.

## Indications for use
The CU580 is intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the chair and attached dental devices. It delivers air, water, vacuum, and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental office. It is for use by authorized persons in the practice of dentistry, prosthodontites, oral surgery, orthodontics, and oral hygeine.

Source page: https://510kreport.com/device/K043496
Methodology: https://510kreport.com/methodology