# K032543: Sirona Dental Systems C8+Dental Operative Unit with Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Nov 14, 2003 after 88 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). 2 ancestors in all.
20 later devices descend from it; 6 cite it directly.
0 of 23 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.
- K962071: Spirit S1/S2, Pelton & Crane Co. (1996) Summary page 1.

## Most influential descendants
- K080438: Dental Unit with Chair (2008), 7 descendants of its own
- K151045: TENEO Dental Treatment Unit and Accessories (2015), 4 descendants of its own
- K130410: Dental Unit with Chair (2013), 4 descendants of its own
- K142206: Dental Unit (2015), 3 descendants of its own
- K052470: F1 Series Dental Chairs with Operative Unit (2005), 3 descendants of its own

## Indications for use
The C8+ Dental Operative Unit with accessories is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic environment and used by trained dentists and/or dental technicians and assistants. The C8+ Dental Operative Unit is offered with the optional Sivision 3, an intraoral camera system intended to provide the dentist and patient with intraoral video images to view the condition of the teeth and oral cavity.

Source page: https://510kreport.com/device/K032543
Methodology: https://510kreport.com/methodology