# K233805: K5

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd. Chair Business
- Decided: Sep 3, 2024 after 279 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). 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)
- K183347: K3, Osstem Implant Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K251491: K5 Cart, K5 Mount, K5 Swing (2025), 0 descendants of its own

## Indications for use
K5 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/K233805
Methodology: https://510kreport.com/methodology