# K152830: K3

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Apr 20, 2017 after 569 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.
8 later devices descend from it; 1 cites it directly.
0 of 11 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 4.

## Most influential descendants
- K183347: K3 (2019), 7 descendants of its own
- K233921: Luvis Chair (LC700C) (2024), 1 descendant of its own
- K233805: K5 (2024), 1 descendant of its own
- K211556: N2 (2023), 1 descendant of its own
- K251491: K5 Cart, K5 Mount, K5 Swing (2025), 0 descendants of its own

## Indications for use
K3 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.

Source page: https://510kreport.com/device/K152830
Methodology: https://510kreport.com/methodology