# K183347: K3

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Sep 4, 2019 after 275 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). 3 ancestors in all.
7 later devices descend from it; 4 cite 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)
- K152830: K3, Osstem Implant Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- 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
- K243130: Integral Dental Unit (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 device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

Source page: https://510kreport.com/device/K183347
Methodology: https://510kreport.com/methodology