# K161488: ESTETICA Dental Treatment Unit and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Kaltenbach & Voigt GmbH
- Decided: Dec 8, 2016 after 190 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: 4 generations back to K962071 (1996). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151045: TENEO Dental Treatment Unit and Accessories, Sirona Dental Systems GmbH (2015) Summary page 4.

## Most influential descendants
- K171872: P50 Series Dental Operative Unit and Accessories (2018), 0 descendants of its own

## Indications for use
The ESTETICA Dental Treatment Unit and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The ESTETICA Dental Treatment Unit and Accessories are designed for use by a trained professional in the field of general dentistry.

Source page: https://510kreport.com/device/K161488
Methodology: https://510kreport.com/methodology