# K151045: TENEO Dental Treatment Unit and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Jul 24, 2015 after 95 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). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 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 4.
- K102234: A-Dec 200 Dental System, A-Dec, Inc. (2010) Summary page 4.

## Most influential descendants
- K233865: X-Smart Pro; X-Smart Pro+ (2024), 1 descendant of its own
- K161488: ESTETICA Dental Treatment Unit and Accessories (2016), 1 descendant of its own
- K251811: Motor and Apex Module (MaAM) (2025), 0 descendants of its own
- K171872: P50 Series Dental Operative Unit and Accessories (2018), 0 descendants of its own

## Indications for use
The dental treatment 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 dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants. The motors serve as drives for rotating and oscillating straight and contra-angle hand pieces in connection with a dental treatment unit. They are used for endodontic and general dental purposes. The SPRAYVIT M multifunctional syringe is used for dental treatment with unheated air and heated water. It is also used to illuminate the preparation field.

Source page: https://510kreport.com/device/K151045
Methodology: https://510kreport.com/methodology