# K041458: Mare Dental Operative Unit

- Pathway: 510(k) (Traditional)
- Applicant: Denimed Electronica S.H.
- Decided: Aug 24, 2004 after 84 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.
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)
- K032543: Sirona Dental Systems C8+Dental Operative Unit with Accessories, Sirona Dental Systems GmbH (2003) Summary page 1.
- K962071: Spirit S1/S2, Pelton & Crane Co. (1996) Summary page 1.

## Indications for use
The Mare Dental Operative Unit and Accessories is intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental office.

Source page: https://510kreport.com/device/K041458
Methodology: https://510kreport.com/methodology