# K983242: Sirona C8 Dental Operative Unit with Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Dec 11, 1998 after 86 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: 1 generation back to K962071 (1996). 1 ancestor in all.
32 later devices descend from it; 5 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962071: Spirit S1/S2, Pelton & Crane Co. (1996) Summary page 1.

## Most influential descendants
- K032543: Sirona Dental Systems C8+Dental Operative Unit with Accessories (2003), 20 descendants of its own
- K152830: K3 (2017), 8 descendants of its own
- K183347: K3 (2019), 7 descendants of its own
- K080438: Dental Unit with Chair (2008), 7 descendants of its own
- K151045: TENEO Dental Treatment Unit and Accessories (2015), 4 descendants of its own

## Indications for use
This product is a Dental Operative Unit with accessories that 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 Ly trained dentists ancl/ or dental technicians and assistants.

Source page: https://510kreport.com/device/K983242
Methodology: https://510kreport.com/methodology