# K150909: INTEGO Family and Accesories

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Jul 17, 2015 after 105 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.
1 later device descends from it; 1 cites it directly.
0 of 6 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
- K251811: Motor and Apex Module (MaAM) (2025), 0 descendants of its own

## Indications for use
The INTEGO Family of Dental Treatment Units with accessories is intended to supply power to and serve as a base for dental devices and accessories. Each unit includes a dental chair. The units are intended for use in the dental clinic environment and are used by trained dentists and/or dental assistants. The MOTOR BL ISO E is used to drive rotating and oscillating straight and contra-angle handpieces in connection with the dental treatment units for endodontic and general dental purposes. The SPRAYVIT E multifunctional syringe is used for dental treatment with unheated air and unheated water. The SPRAYVIT E multifunctional syringe is also used to illuminate the preparation field.

Source page: https://510kreport.com/device/K150909
Methodology: https://510kreport.com/methodology