# K251491: K5 Cart, K5 Mount, K5 Swing

- Pathway: 510(k) (Special)
- Applicant: Osstem Implant Company., Ltd. Chair Business
- Decided: Jul 17, 2025 after 64 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: 5 generations back to K962071 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233805: K5, Osstem Implant Co., Ltd. Chair Business (2024) Summary page 5.

## Indications for use
K5 is intended to supply power to and serve as a base for dental devices and accessories. This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and supplying water into the oral cavity through a water line in dental clinical environments.

Source page: https://510kreport.com/device/K251491
Methodology: https://510kreport.com/methodology